Neoplasms

All Conditions

Rare Diseases

Neuroendocrine Tumors

Carcinoid Tumor

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Tyrosine Kinase Inhibitors

Nintedanib

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis

Pharmacological Study

Quality-of-Life Assessment

Renuka Iyer

This phase II trial studies how well nintedanib works in treating patients with neuroendocrine tumors that have spread from where they started to nearby tissue or lymph nodes (locally advanced) or have spread from the primary site (place where they started) to other places in the body (metastatic). Nintedanib may stop the growth of tumor cells by slowing or stopping a certain type of receptor called vascular endothelial growth factor receptor (VEGFR) from attaching to its target. This may stop the growth of neuroendocrine tumors by blocking the growth of new blood vessels necessary for tumor growth.

PRIMARY OBJECTIVES:

I. To assess progression free survival (PFS), defined as the time interval from initiation of therapy, to its cessation for documentation of progressive disease (PD) or death.

SECONDARY OBJECTIVES:

I. To assess the clinical response (complete response + partial response) in all patients with measurable disease (using standard Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\]1.1 criteria).

II. To assess overall survival (OS) in all patients. III. Assess changes in quality of life (QOL) throughout treatment using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) - Gastrointestinal Neuroendocrine Tumors (NET) 21 (GI.NET21) questionnaire for carcinoid patients with gastrointestinal neuroendocrine tumors, in all patients who have filled out at least two QOL questionnaires and, will be reported by groups based on response (response, stable disease or progressive disease).

IV. Steady-state pharmacokinetics (PK) of nintedanib, biomarkers, regulatory T cell (Treg) and cytokine expression and growth factors will be analyzed for all patients and reported in groups based on response.

V. Gene mutations and copy number alterations analysis in the mammalian target of rapamycin (mTOR) pathway (will be performed only on the first 10 patients), protein expression of activation of protein kinase B (Akt) (as well as other downstream targets).

VI. Toxicity (graded using the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.0) will be closely monitored and all toxicities will be tabulated.

OUTLINE:

Patients receive nintedanib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3 months for 2 years.

Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors

Multicenter Phase 2 Study of Nintedanib for Patients With Advanced Carcinoid Tumors

Will be analyzed for all patients and reported in groups based on response.

Will be analyzed for all patients and reported in groups based on response. Changes in pre- and post-treatment cytokine expression will be analyzed using permutation paired t-tests.

Will be analyzed for all patients and reported in groups based on response. Changes in pre- and post-treatment growth factors will be analyzed using permutation paired t-tests.

Gene mutations and copy number alterations in the several pathways particularly mTOR pathway will be evaluated. Will be analyzed for all patients and correlated with clinical outcomes.

Will be reported using standard Kaplan-Meier methods. Ninety percent confidence intervals for the median PFS will be calculated using Greenwood's formula. Additionally, a confidence interval for the 16-week PFS rate will be obtained using Jeffrey's prior method. The association between survival and quantified variables will be investigated using the Cox-proportional hazard model.

Quality of life will be investigated calculated by Subjects filing out EORTC Gastrointestinal Neuroendocrine Tumour 21 Questionnaire (QLQ-GI.NET21) A 21 question questionnaire that use a 4-point scale (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). The scores for different scales (i.e. endocrine, gastrointestinal, treatment, social function, disease Related, and global) are calculated by summing related questions from the questionnaire. The range of the subscale scores are from 0 to 100, with higher scores being worse.

After the subscale scores being calculated, the Change in quality of life is calculated by subtracting baseline score from end of treatment

Sample collection will be obtained at baseline and week 8

Exact 90% confidence interval estimates using the Clopper-Pearson method will be given for the response rates. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI, response rates are categorized as Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Will be reported using standard Kaplan-Meier methods. Ninety-five percent confidence intervals for the median OS will be calculated using Greenwood's formula. The association between survival and quantified variables will be investigated using the Cox-proportional hazard model.

Scores will be obtained to investigate association with PFS, clinical response, QOL and survival.

National Comprehensive Cancer Network

Roswell Park Cancer Institute

Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Nintedanib: Given PO

Pharmacological Study: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Treatment (Nintedanib)

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Katy Wang

Change in endocrine scale

Change in gastrointestinal scale

Change in treatment scale

Change in social function scale

Change in Disease Related Worry Scale

Change in Global scale

Patients completed at least 2 EORTC QLQ-GI.NET21 questionnaires are included for this outcome estimate

Change in Quality of Life Score

Plasma Concentrations at Steady State (Cpre,ss) of Nintedanib at Baseline and Week 8

Clinical Response (Complete Response + Partial Response) Measured Using Standard RECISTv1.1 Criteria

Median OS

The FGFR IIIb/IIIcm, Ki-67m and microvessel density scores were not measured (i.e. data not obtained) and analyses were not performed.

Ratio of FGFR IIIb/IIIc and Ki-67 and Microvessel Density Scores

The appropriate biomarkers were not measured (i.e. data not obtained) and analyses were not performed.

Biomarker Levels

The appropriate cytokine expressions were not measured (i.e. data not obtained) and analyses were not performed.

Change in Cytokine Expression

The appropriate growth factors were not measured (i.e. data not obtained) and analyses were not performed.

Change in Growth Factors

Gene mutations and copy number alterations were not measured (i.e. data not obtained) and analyses were not performed.

Gene Mutations and Copy Number Alterations

Treg levels were not measured and analyses were not performed.

Treg Levels

Overall Study

Symptoms and General Pathology

Gland and Hormone Related Diseases

Infections

Diseases and Abnormalities at or Before Birth

Digestive System Diseases

Syndrome

Recurrence

Thyroid Diseases

Pheochromocytoma

Endocrine Gland Neoplasms

Adrenocortical Carcinoma

Carcinoma, Medullary

Carcinoma, Merkel Cell

Multiple Endocrine Neoplasia

Insulinoma

Multiple Endocrine Neoplasia Type 1

Gastrinoma

Multiple Endocrine Neoplasia Type 2a

Multiple Endocrine Neoplasia Type 2b

Glucagonoma

Vipoma

Somatostatinoma

Zollinger-Ellison Syndrome

Adenoma

Adenoma, Islet Cell

Thyroid Neoplasms

Carcinoma, Neuroendocrine

Disease Attributes

Endocrine System Diseases

Paraganglioma

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Head and Neck Neoplasms

Neoplasms, Multiple Primary

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Carcinoma, Islet Cell

Paraneoplastic Syndromes

Ulcer

Peptic Ulcer

Duodenal Diseases

Intestinal Diseases

Stomach Diseases

Adrenal Cortex Neoplasms

Adrenal Gland Neoplasms

Adrenal Cortex Diseases

Adrenal Gland Diseases

Pancreatic Neuroendocrine Tumor

Thyroid Cancer, Medullary

Merkel Cell Carcinoma

Non Functioning Pancreatic Endocrine Tumor

Multiple Endocrine Neoplasia Type 2

Multiple Endocrine Neoplasia Type 2A

Multiple Endocrine Neoplasia Type 2B

Functioning Pancreatic Endocrine Tumor

VIPoma

Paragangliomas 1

Pancreatic Cancer

Capecitabine

Temozolomide

Veliparib

Antimetabolites

Antineoplastic Agents, Alkylating

Alkylating Agents

Poly(ADP-ribose) Polymerase Inhibitors

Capecitabine PO BID on days 1-14, temozolomide PO BID on days 10-14 and veliparib PO BID on days 10-14.

Jordan Berlin, M.D.

This phase I trial studies the side effects and best dose of veliparib when given together with capecitabine and temozolomide in treating patients with neuroendocrine tumor that has spread to other places in the body and usually cannot be cured or controlled with treatment, has returned after a period of improvement, and cannot be removed by surgery. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) of veliparib (ABT-888) in combination with capecitabine and temozolomide in patients with advanced well-differentiated neuroendocrine tumors.

SECONDARY OBJECTIVES:

2. To determine the safety profile of the combination of capecitabine, temozolomide and veliparib in patients with advanced well-differentiated neuroendocrine tumors (NET).

3. To evaluate the antitumor activity of the combination of capecitabine, temozolomide and veliparib in advanced well-differentiated NET patients

4. To determine progression-free survival (PFS) of the combination of capecitabine, temozolomide, and veliparib in advanced well-differentiated NET patients IV. To evaluate the association between pharmacodynamic biomarkers and response in patients with advanced well-differentiated NET patients.

OUTLINE: This is a dose-escalation study of veliparib.

Patients receive capecitabine orally (PO) twice daily (BID) on days 1-14, temozolomide PO BID on days 10-14 and veliparib PO BID on days 10-14. Courses repeat every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Veliparib, Capecitabine, and Temozolomide in Patients With Advanced, Metastatic, and Recurrent Neuroendocrine Tumor

A Phase 1 Study of Veliparib (ABT-888) in Combination With Capecitabine and Temozolomide in Advanced Well-Differentiated Neuroendocrine Tumors

National Cancer Institute (NCI)

Vanderbilt-Ingram Cancer Center

Professor of Medicine

Substance Related Disorders

Malignant Carcinoid Syndrome

Serotonin Syndrome

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Gastro-enteropancreatic Neuroendocrine Tumor

Carcinoid Syndrome

Patients undergo one dual energy CT scan during scheduled CT scan.

Dual-Energy Computed Tomography

Ajaykumar Morani, MD

Ajaykumar Morani

This trial studies the use of a special type of computed (CT) scan called dual energy CT in detecting gastrointestinal carcinoid tumors. CT is an imaging technique that uses x-rays and a computer to create images of areas inside the body. Dual energy computed tomography is a technique used during routine CT scans to help obtain and process the image after the scan is complete. Doctors want to learn if dual energy computed tomography can help improve the detection of carcinoid tumors during routine CT scans.

PRIMARY OBJECTIVES:

I. Evaluate prospectively the sensitivity and specificity of dual energy computed tomography (CT) in detecting primary gastrointestinal (GI) carcinoid.

OUTLINE:

Patients undergo one dual energy CT scan during scheduled CT scan.

An Investigational Scan (Dual Energy CT) in Detecting Gastrointestinal Carcinoid Tumors

Evaluation of Dual Energy CT for the Detection of Gastrointestinal Carcinoids

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors	NCT02399215	Carcinoid Tumor Metastatic Carc... Neuroendocrine ...	Laboratory Biom... Nintedanib Pharmacological... Quality-of-Life...	18 Years -	Roswell Park Cancer Institute
Veliparib, Capecitabine, and Temozolomide in Patients With Advanced, Metastatic, and Recurrent Neuroendocrine Tumor	NCT02831179	Functional Panc... Malignant Somat... Merkel Cell Car... Metastatic Adre... Metastatic Carc... Multiple Endocr... Multiple Endocr... Multiple Endocr... Neuroendocrine ... Non-Functional ... Pancreatic Gluc... Pancreatic Insu... Recurrent Adren... Recurrent Adren... Recurrent Merke... Somatostatin-Pr... Stage III Adren... Stage III Thyro... Stage IIIA Merk... Stage IIIB Merk... Stage IV Adrena... Stage IV Merkel... Stage IVA Thyro... Stage IVB Thyro... Stage IVC Thyro... Thymic Carcinoi... VIP-Producing N... Well Differenti... Zollinger Ellis...	Capecitabine Temozolomide Veliparib Pharmacological... Laboratory Biom...	18 Years -	Vanderbilt-Ingram Cancer Center
An Investigational Scan (Dual Energy CT) in Detecting Gastrointestinal Carcinoid Tumors	NCT04993261	Carcinoid Syndr... Carcinoid Tumor Digestive Syste... Metastatic Carc...	Dual-Energy Com...	18 Years -	M.D. Anderson Cancer Center
Veliparib, Capecitabine, and Temozolomide in Patients With Advanced, Metastatic, and Recurrent Neuroendocrine Tumor	NCT02831179	Functional Panc... Malignant Somat... Merkel Cell Car... Metastatic Adre... Metastatic Carc... Multiple Endocr... Multiple Endocr... Multiple Endocr... Neuroendocrine ... Non-Functional ... Pancreatic Gluc... Pancreatic Insu... Recurrent Adren... Recurrent Adren... Recurrent Merke... Somatostatin-Pr... Stage III Adren... Stage III Thyro... Stage IIIA Merk... Stage IIIB Merk... Stage IV Adrena... Stage IV Merkel... Stage IVA Thyro... Stage IVB Thyro... Stage IVC Thyro... Thymic Carcinoi... VIP-Producing N... Well Differenti... Zollinger Ellis...	Capecitabine Temozolomide Veliparib Pharmacological... Laboratory Biom...	18 Years -	Vanderbilt-Ingram Cancer Center
An Investigational Scan (Dual Energy CT) in Detecting Gastrointestinal Carcinoid Tumors	NCT04993261	Carcinoid Syndr... Carcinoid Tumor Digestive Syste... Metastatic Carc...	Dual-Energy Com...	18 Years -	M.D. Anderson Cancer Center

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