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Gastrointestinal Diseases

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Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Anti-Infective Agents

Capecitabine

Cisplatin

Pancreatic Polypeptide

Streptozocin

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

capecitabine

cisplatin

streptozocin

DNA analysis

RNA analysis

protein analysis

proteomic profiling

laboratory biomarker analysis

Pippa Corrie, PhD, FRCP

Tim Meyer, MD, BSc, MRCP, PhD

RATIONALE: Drugs used in chemotherapy, such as capecitabine, streptozocin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving capecitabine together with streptozocin is more effective with or without cisplatin in treating neuroendocrine tumors.

PURPOSE: This randomized phase II trial is studying giving capecitabine together with streptozocin to see how well it works compared with or without cisplatin in treating patients with unresectable or metastatic neuroendocrine tumors.

OBJECTIVES:

Primary

* To determine the objective response rate in patients with neuroendocrine tumors treated with capecitabine and streptozocin with or without cisplatin.

Secondary

* To determine the overall response rate, including both objective and biochemical responses, to these regimens.
* To determine the functional response to these regimens.
* To determine the toxicity of these regimens.
* To identify the optimal drug doses in each regimen to be recommended for a subsequent phase III trial.
* To determine the progression-free and overall survival of patients receiving these regimens.
* To determine the quality of life of these patients.
* To determine molecular markers predictive of response to chemotherapy.

OUTLINE: This is a multicenter study. Patients are stratified according to site of origin (known vs unknown primary site), prior antitumor treatment, tumor function (functional vs nonfunctional), and study center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive streptozocin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-21.
* Arm II: Patients receive cisplatin IV over 2 hours on day 1 and streptozocin and capecitabine as in arm I.

In both treatment arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients complete the EORTC QLQC30 questionnaire and EORTC QLQ-GI.NET21 module for quality-of-life assessment at baseline, every 9 weeks during treatment, and at 12 weeks post-treatment.

Tumor tissue is obtained at baseline and assessed for Ki67 and mitotic index. Novel tissue-specific transcription factors (e.g., CDX2) are also assessed. Blood samples are collected at baseline and 9 weeks and examined by DNA, RNA, and proteomic analysis.

After completion of study therapy, patients are followed every 12 weeks.

Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors

A Randomised Phase II Study Comparing Capecitabine Plus Streptozocin With or Without Cisplatin Chemotherapy as Treatment for Unresectable or Metastatic Neuroendocrine Tumors

Cambridge University Hospitals NHS Foundation Trust

Carcinoma, Neuroendocrine

Everolimus

Octreotide

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Hormonal

Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day.

Stratum 2 patients who were to receive everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot therapy.

Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.

Participants took two 5 mg tablets of Everolimus orally with a glass of water, once daily (preferably in the morning) in a fasting state or after no more than a light, fat-free meal. Dosing was to occur at the same time each day. If vomiting occurred, the vomited dose was not to be replaced.

Everolimus 10 mg

Octreotide Depot

Novartis Pharmaceuticals

The purpose of this study was to assess the efficacy and safety of everolimus in the treatment of advanced pancreatic neuroendocrine tumor (NET) not responsive to cytotoxic chemotherapy. All patients were treated with everolimus until either tumor progression was documented using a standard criteria that measures tumor size called Response Evaluation Criteria in Solid tumors (RECIST), or until unacceptable toxicity occurred, or until the patient or investigator requested discontinuation of treatment.

This was a stratified two-stage, single-arm, phase 2 study of treatment with everolimus in patients with advanced (unresectable or metastatic) pancreatic neuroendocrine tumor (NET) after failure of cytotoxic chemotherapy.

Stratum 1, consisted of patients not receiving chronic Octreotide Depot therapy, will receive everolimus monotherapy at 10 mg/day.

Stratum 2, consisting of patients with tumors that have progressed during Octreotide Depot treatment will continue their entry dose of Octreotide Depot plus everolimus 10 mg/day.

Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy

An Open Label, Stratified, Single-arm Phase II Study of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumor (NET) After Failure of Cytotoxic Chemotherapy

Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.

Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR):

* Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression.
* Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.

Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions

Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed.

Median PFS was obtained and displayed along with 95% confidence intervals.

Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause.

If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed.

For all patients in both strata, a blood sample for everolimus trough level determination will be collected immediately prior to the everolimus administration on Cycle 1 Day 15, Cycle 2 Day 1, and every month thereafter. A treatment cycle was defined as 28 days of consecutive daily treatment with everolimus and treatment continued until tumor progression. It is critical that patients not take their daily everolimus dose before the sample is drawn.

The effect of Octreotide Depot on the trough concentrations of everolimus was assessed at Cycle 1 Day 15.

Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.

Stratum 1: Everolimus 10 mg

Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.

Stratum 2: Everolimus 10 mg + Octreotide Depot

Total

Age Continuous

Sex: Female, Male

Novartis Study Director

The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.

Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)

Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus. Only those patients whose best overall response was complete response (CR) or partial response (PR) were included in this analysis.

Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review

Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.

Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.

Very low number of patients demonstrated a partial response, the median duration of response as per central review has not been calculated.

Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review

Full Analysis Set (FAS) was consisted of all patients who received at least one dose of everolimus.

Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)

Adverse Events

Death

Serious Adverse Events

The safety population consists of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment.

Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1]

Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2]

Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1)

Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2)

The full analysis set consisted of all patients who received at least one dose of everolimus.

Time to Overall Survival (OS)(Stratum 1)

Time to Overall Survival (OS) (Stratum 2)

Full Analysis Set (FAS) is consisted of all patients who received at least one dose of everolimus. Patients with everolimus pharmacokinteic samples, with nonzero concentration, at Cycle 1 Day 15 were included

Everolimus Trough Level Determination by Pharmacokinetics Parameter in Both Strata (Stratum 1 and 2)

Cycle 1 Day 1 (pre-treatment baseline) (n=37)

Cycle 2 Day 1 (n= 38)

Full Analysis Set (FAS) is consisted of all patients who received at least one dose of everolimus. Patients with Octreotide Depot pharmacokinetic samples, with nonzero concentration, at Cycle 1 Day 1 or Cycle 2 Day 1 were included.

Effect of Octreotide Depot on the Trough Concentrations of Everolimus

Overall Study

WDHA Syndrome

Amino Acids

Hormones

Somatostatin

Mitogens

Tyrosine Kinase Inhibitors

Vatalanib

Hormone Antagonists

Tyrosine

octreotide acetate

vatalanib

anti-cytokine therapy

antiangiogenesis therapy

biological therapy

endocrine therapy

enzyme inhibitor therapy

growth factor antagonist therapy

hormone therapy

protein tyrosine kinase inhibitor therapy

somatostatin analogue therapy

Kyle Holen, MD

Mary Mulcahy, MD

RATIONALE: Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by stopping blood flow to the tumor. Octreotide may help control symptoms, such as diarrhea, caused by the tumor. Giving vatalanib together with octreotide may be an effective treatment for neuroendocrine tumors.

PURPOSE: This phase II trial is studying how well giving vatalanib together with octreotide works in treating patients with progressive neuroendocrine tumors.

OBJECTIVES:

* Determine the 4-month progression-free and overall survival of patients with progressive low-grade neuroendocrine tumors treated with vatalanib and octreotide.
* Determine the response rate in patients treated with this regimen.
* Determine the effect of this regimen on tumor markers (e.g., chromogranin A, 5-HIAA, and gastrin) in these patients.
* Determine the toxicity and tolerability of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral vatalanib once daily on days 1- 28 and octreotide\* intramuscularly or IV on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: \*Patients on a stable dose (i.e., no changes in dosage within the past 3 months) of octreotide before study entry remain on their current dose and schedule during study participation; patients who experience hypersensitivity and/or toxicity to octreotide may receive vatalanib alone.

After completion of study treatment, patients are followed at 4 weeks, every 3 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 23-44 patients will be accrued for this study within 3 years.

Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors

Phase II Study of Vatalanib and Octreotide in Patients With Progressive Low-Grade Neuroendocrine Tumors

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days.

Starting dose of 5 or 10 mg by mouth daily.

RAD001

30 mg injection into the muscle of either buttock once every 28 (±7) days.

James Yao, M.D.

Objectives:

Primary endpoint:

-Assess the clinical activity of RAD 001 plus depot octreotide as defined by progression free survival (PFS) duration defined by RECIST criteria in treated and untreated patients with metastatic, unresectable low grade neuroendocrine carcinoma.

Secondary endpoints:

* Assess the progression free survival duration of patients with metastatic, unresectable low grade neuroendocrine carcinoma treated with RAD 001 plus depot octreotide.
* Assess the safety of RAD 001 plus depot octreotide in patients with metastatic, unresectable low grade neuroendocrine carcinoma.
* To determine the expression/phosphorylation status of the components of the mTOR signaling pathway in the primary tumors, in order to determine whether these markers can be used as predictors of sensitivity to the combination of RAD001 and octreotide.
* To determine the effect of the combination of RAD001 and octreotide on the expression and phosphorylation of mTOR's targets in the accessible tumor tissue, in order to identify potential pharmacodynamics markers of response to this drug combination.
* To observe the effects of treatment with RAD001 on plasma angiogenic biomarkers.

RAD001 is a new drug that is designed to block a protein that is important in the growth of cancer cells. Octreotide Depot is FDA approved for the treatment of carcinoid syndrome and hormonal symptoms from certain islet cell carcinomas. Octreotide Depot may also help to block certain proteins that are important in tumor growth.

Before you can start treatment on the study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will be asked questions about your medical history and about any medications you are currently taking or have taken in the past. You will have a complete physical exam and your heart rate, temperature, breathing rate, blood pressure, height, and weight will be measured. You will be asked about your ability to perform every day activities. Blood (about 2 teaspoons) will be collected for routine tests. You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart) and scans (either Computed Tomography/CT or Magnetic Resonance Imaging/MRI) to evaluate the cancer. Women who are able to have children must have a negative blood pregnancy test.

If the screening evaluations show you are eligible to take part in the study, you may begin treatment. You will take RAD001 by mouth once a day, every day while on study. You should take it in a fasting state or after no more than a light, fat-free meal. You should take RAD001 about the same time each day. Octreotide Depot will be given as an injection into the muscle of either buttock once every 4 weeks while on study. This will be done at M. D. Anderson. Four weeks (28 days) is called one course of treatment.

Clinic visits will occur every 2 weeks during the first 4 weeks and every 4 weeks from then on. At each clinic visit, you will be asked questions about your medical history and about any medications you are currently taking or have taken in the past. You will have a complete physical exam and your heart rate, temperature, breathing rate, blood pressure, height, and weight will be measured. You will be asked about your ability to perform every day activities. Blood samples (about 1 teaspoons) for routine tests will be collected every 2 weeks for the first 8 weeks. After that, blood samples (about 2 teaspoons) will be collected every 4 weeks. CT or MRI scan(s) will be performed every 12 weeks.

If a sample of your tumor tissue that was removed previously is available, it will be analyzed for expression of proteins that may effect tumor growth. However, if a sample is not available, you will not be asked to undergo a biopsy to collect this tissue. This sample may analyzed at any time during the study.

If you experience severe side effects, treatment may be delayed, stopped, or you may receive smaller doses of RAD001 and/or Octreotide Depot. You may continue to receive up to at least 12 courses of study treatment unless the disease gets worse, you decide not to take part any longer, or your doctor decides it is in your best interest to stop treatment. It may be possible to continue treatment beyond 12 courses if you are benefitting from this treatment.

When you stop study treatment, you will be asked to have some tests and evaluations done. About 4 teaspoons of blood will be taken for routine lab tests, You will also have a physical exam and CT scan or MRI scan will be done to check the size and location of your disease.

This is an investigational study. RAD001 is investigational and is not commercially available. The drug combination in this study is also investigational. RAD001 is manufactured by Novartis Pharmaceuticals Corporation. About 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

RAD001 Plus Octreotide Depot in Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma

Phase II Study of RAD001 Plus Octreotide Depot in Patients With Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma (Carcinoid, Islet Cell)

PFS is measured from date of trial entry until documented progression of disease or death from any cause. PFS is measured by computed tomography (CT) scans or magnetic resonance imaging (MRI) performed at baseline and after every three cycles.

M.D. Anderson Cancer Center

RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days

RAD001 Plus Octreotide Depot

Age, Continuous

United States

Region of Enrollment

James Yao, M.D./Associate Professor

Progression Free Survival (PFS)

Gastro-enteropancreatic Neuroendocrine Tumor

Micronutrients

Irinotecan

Leucovorin

Fluorouracil

Oxaliplatin

Lenograstim

Folfirinox

Pancrelipase

Pancreatin

Adjuvants, Immunologic

Participants will receive modified FOLFIRINOX which consists of 85 mg/m\^2 of oxaliplatin, 400 mg/m\^2 of leucovorin over the first 2 hours, 165 mg/m\^2 of irinotecan in a 90-minute infusion on day 1, followed by a continuous, 46-hour infusion of 5-FU at a dosage of 2,400 mg/m\^2. A cycle will be repeated every 14 days. Granulocyte colony-stimulating factor (G-CSF) prophylaxis will be allowed after each cycle. Participants will undergo re-staging studies every 8 weeks. Participants will receive up to 12 cycles during the study. Additional cycles will be determined per investigators' discretion.

The FOLFIRINOX regimen consists of oxaliplatin given as a 2-hour intravenous infusion, immediately followed by leucovorin given as a 2-hour intra-venous infusion, with the addition, after 30 minutes, of irinotecan given as a 90-minute intravenous infusion. This study treatment is immediately followed by a continuous intravenous infusion of 5-Fluorouracil (5-FU) over a 46-hour period every 2 weeks.

FOLFIRINOX

The use of G-CSF will not be mandatory as primary prophylaxis, but will be allowed at investigators' discretion. If febrile neutropenia occurs, than the use of G-CSF will be mandatory after each following cycle of treatment.

Granulocyte colony-stimulating factor (G-CSF)

Jonathan Strosberg, M.D.

The purpose of this study is evaluate the efficacy and safety of FOLFIRINOX in patients with gastroenteropancreatic high-grade neuroendocrine carcinomas.

This is a prospective Phase II open-label trial, stratifying gastroenteropancreatic high grade neuroendocrine carcinomas participants equally into two cohorts (first-line versus beyond first-line).

FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

Phase II Trial of FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

Safety analysis will be analyzed by collecting date on treatment-related morbidity and mortality. Investigators will collect data on frequency, type and severity of all adverse events that occur on or after Cycle 1, Day 1 according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE; Version 4.0).

The primary efficacy endpoint is objective response rate as determined by radiology review, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR): complete disappearance of all target lesions. Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). Stable Disease (SD): neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease.

PFS: from initiation date of therapy to disease progression or death. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum).

H. Lee Moffitt Cancer Center and Research Institute

Participants received modified FOLFIRINOX which consists of 85 mg/m\^2 of oxaliplatin, 400 mg/m\^2 of leucovorin over the first 2 hours, 165 mg/m\^2 of irinotecan in a 90-minute infusion on day 1, followed by a continuous, 46-hour infusion of 5-FU at a dosage of 2,400 mg/m\^2. A cycle will be repeated every 14 days. Granulocyte colony-stimulating factor (G-CSF) prophylaxis will be allowed after each cycle.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors	NCT00602082	Gastrointestina... Islet Cell Tumo...	capecitabine cisplatin streptozocin DNA analysis RNA analysis protein analysi... proteomic profi... laboratory biom...	18 Years -	National Cancer Institute (NCI)
Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy	NCT00363051	Islet Cell Carc... Neuroendocrine ... Neuroendocrine ... Pancreatic Neop...	Everolimus 10 m... Octreotide Depo...	18 Years -	Novartis
Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors	NCT00227773	Gastrointestina... Islet Cell Carc...	octreotide acet... vatalanib anti-cytokine t... antiangiogenesi... biological ther... endocrine thera... enzyme inhibito... growth factor a... hormone therapy protein tyrosin... somatostatin an...	18 Years - 120 Years	Eastern Cooperative Oncology Group
RAD001 Plus Octreotide Depot in Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma	NCT00113360	Neuroendocrine ... Islet Cell Carc...	RAD001 Octreotide Depo...	18 Years -	M.D. Anderson Cancer Center
FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas	NCT03042780	Gastro-enteropa... Pancreatic Canc... Neuroendocrine ... Islet Cell Carc...	FOLFIRINOX Granulocyte col...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors	NCT00227773	Gastrointestina... Islet Cell Carc...	octreotide acet... vatalanib anti-cytokine t... antiangiogenesi... biological ther... endocrine thera... enzyme inhibito... growth factor a... hormone therapy protein tyrosin... somatostatin an...	18 Years - 120 Years	Eastern Cooperative Oncology Group
Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors	NCT01824875	Gastrinoma Glucagonoma Insulinoma Islet Cell Carc... Pancreatic Poly... Recurrent Islet... Somatostatinoma	temozolomide capecitabine	18 Years -	Eastern Cooperative Oncology Group

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