Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Gland and Hormone Related Diseases

Substance Related Disorders

Rare Diseases

Carcinoma

Adenoma

Recurrence

Neuroendocrine Tumors

Adenoma, Islet Cell

Carcinoid Tumor

Carcinoma, Islet Cell

Insulinoma

Gastrinoma

Glucagonoma

Somatostatinoma

Zollinger-Ellison Syndrome

Syndrome

Malignant Carcinoid Syndrome

Serotonin Syndrome

Gastrointestinal Neoplasms

Digestive System Neoplasms

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Gastrointestinal Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Carcinoid Syndrome

Neuroepithelioma

Pancreatic Cancer

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

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

Antibodies

Antibodies, Monoclonal

Fluorouracil

Vincristine

Immunoglobulins

Carmustine

Immunologic Factors

Immunosuppressive Agents

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Cola

monoclonal antibody A33

carmustine

fluorouracil

vincristine sulfate

Sydney Welt, MD

RATIONALE: Monoclonal antibodies can find and locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy plus combination chemotherapy in treating patients with advanced colorectal cancer.

OBJECTIVES: I. Define toxicity and the maximum tolerated dose of humanized monoclonal antibody A33 (MOAB A33) when combined with carmustine, fluorouracil, vincristine, and streptozocin in patients with advanced colorectal cancer. II. Determine the effect of chemotherapy on human antihuman antibody response and on the pharmacokinetics of humanized MOAB A33 in these patients. III. Define the humanized MOAB A33 dose for a phase II study.

OUTLINE: This is a dose escalation study of humanized monoclonal antibody A33 (MOAB A33). Patients receive humanized MOAB A33 IV once a week for 14 weeks. Chemotherapy begins on day 29 and consists of carmustine IV on days 29-33, fluorouracil IV on days 29-33 and 64-68, vincristine IV on days 29 and 64, and streptozocin IV every 7 days, beginning on day 29, for 10 doses. Courses repeat every 14 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of humanized MOAB A33. The maximum tolerated dose is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: There will be 3-18 patients accrued into this study over 2-9 months.

Monoclonal Antibody Therapy Plus Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

Phase I Study of Combination Immunochemotherapy in Patients With Advanced Colorectal Carcinoma

National Cancer Institute (NCI)

Memorial Sloan Kettering Cancer Center

Micronutrients

Hematinics

Vitamins

Bevacizumab

Leucovorin

Levoleucovorin

Temozolomide

Folic Acid

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Folinic Acid

Folate

Vitamin B9

LV5FU2 (Folinic Acid D, L 400 mg/m² day 1, 5FU 400 mg/m² IV bolus, 5FU 2400 mg/m² 48 hours continuous infusion)

LV5FU2

streptozotocin 800 mg/m² day 1 every 14 days

Capecitabine 750 mg/m² twice daily, days 1-14

temozolomide 200 mg/m² once daily, days 10-14, every 28 days

Compare the effect of capecitabine (cape) + temozolomide (temo) and of 5FU + streptozotocin (strepto) given with a new schedule (LV5FU2 + strepto), two of the most used chemotherapy regimens in the treatment of well differentiated pancreatic neuroendocrine tumors alone or in combination with bevacizumab (beva) on progression-free survival (PFS) and compare the chemotherapy regimens alone or with beva (two by two design) on the same criteria.

Comparative phase II trial with two randomizations

Two Chemotherapy Regimens Plus or Minus Bevacizumab

Randomized Phase 2 Trial Of Two Chemotherapy Regimens Plus Or Minus Bevacizumab In Patients With Well Differentiated Pancreatic Neuroendocrine Tumors

National Cancer Institute, France

Gustave Roussy, Cancer Campus, Grand Paris

Anti-Inflammatory Agents

Antiemetics

Dermatologic Agents

Doxorubicin

Liposomal doxorubicin

Dexamethasone

Ondansetron

Dexamethasone acetate

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Serotonin

Serotonin 5-HT3 Receptor Antagonists

Neurotransmitter Agents

Protocol Specified Chemotherapy Every 28 Days: Avastin, Fluorouracil, Doxorubicin, Streptozocin.

Premedications: Dexamethasone, Ondansetron

Every 28 Days: Avastin 5mg/kg iv days 1 and 15

Avastin

Every 28 Days: Fluorouracil 400mg/m\^2 iv bolus daily days 1-5

Every 28 Days: Doxorubicin 40mg/m\^2 iv bolus day 1

Every 28 Days: Streptozocin 400mg/m2 iv bolus daily days 1-5

Premedication: Dexamethasone 20mg intravenously days 1-5

Premedication: Ondansetron 16mg intravenously days 1-5

Larry Kvols, M.D.

Jonathan Strosberg, M.D.

Open label, single-arm phase II study of avastin combined with fluorouracil, doxorubicin and streptozocin administered in 28-day cycles. Treatment will continue until progression of disease, or until withdrawal due to toxicity, or up to a maximum of 12 cycles (48 weeks). In order to reduce the risk of cardiac toxicity, doxorubicin will be administered for a maximum of 8 cycles. If disease has not progressed after 12 cycles of treatment, avastin monotherapy will continue until disease progression or withdrawal due to toxicity.

Patients will need to come for 24 study visits in all. Most study visits will take about 2 hours. At some of these study visits, the doctor

* Will do a physical exam
* Will take blood for routine lab tests
* Will do a urinalysis
* Will administer study medication Some study visits may be longer because patient will have a CT scan or an MRI.

At patient's last visit, they will have a CT scan or MRI.

After treatment starts, patient will:

* Have their blood pressure monitored with every dose of Avastin® (about every 2 weeks).
* Have a history and physical with every chemotherapy cycle (about every 4 weeks).
* Have their blood taken for routine blood tests with every chemotherapy cycle (about every 4 weeks).
* Have a CT scan or MRI during every other cycle (about every 8 weeks).
* Have a MUGA scan during every 4 cycles (about 16 weeks).
* Have blood taken for tumor markers during every cycle only if their markers were high at baseline.
* Patients will receive study medication to treat their cancer:
* Fluorouracil on days 1 through 5 of each cycle through cycle 12
* Doxorubicin on day 1 of each cycle through cycle 8
* Streptozocin on days 1 through 5 of each cycle through cycle 12
* Avastin® on days 1 and 15 of each cycle through cycle 12

Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors

Phase II Study of Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors

We planned to calculate the One Year Progression Free Survival rate. The event for PFS analyses was the first occurrence of disease progression or death and patients who did not progress or died would be censored at the date of last tumor evaluation (e.g. one-year).

Objective Radiographic Response Rate (ORR). We planned to calculate the sum of complete response (CR) and partial response (PR) in target lesions.

Genentech, Inc.

H. Lee Moffitt Cancer Center and Research Institute

Chemotherapy

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

This trial only enrolled one patient and was closed because of development of a new chemotherapy standard of care for treatment of this cancer which we felt rendered the trial obsolete. The trial was open for only 7 months.

Number of Participants With Progression Free Survival (PFS) at 12 Months

The Number of Participants With Radiographic Response

Overall Study

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)
Monoclonal Antibody Therapy Plus Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer	NCT00003543	Colorectal Canc...	monoclonal anti... carmustine fluorouracil streptozocin vincristine sul...	18 Years -	Memorial Sloan Kettering Cancer Center
Two Chemotherapy Regimens Plus or Minus Bevacizumab	NCT03351296	Pancreatic Canc...	LV5FU2 Streptozocin Capecitabine Temozolomide Bevacizumab	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris
Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors	NCT00609765	Pancreatic Canc...	Avastin Fluorouracil Doxorubicin Streptozocin Dexamethasone Ondansetron	18 Years - 80 Years	H. Lee Moffitt Cancer Center and Research Institute
Two Chemotherapy Regimens Plus or Minus Bevacizumab	NCT03351296	Pancreatic Canc...	LV5FU2 Streptozocin Capecitabine Temozolomide Bevacizumab	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris

Spots Global Cancer Trial Database for streptozocin

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