Gastrointestinal Carcinoid Tumor Clinical Trial
Official title:
Phase II Study of Vatalanib and Octreotide in Patients With Progressive Low-Grade Neuroendocrine Tumors
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.
;
Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01048892 -
Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features
|
Phase 1 | |
| Terminated |
NCT00903396 -
Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT00436735 -
Nelfinavir in Treating Patients With Metastatic, Refractory, or Recurrent Solid Tumors
|
Phase 1 | |
| Completed |
NCT00002470 -
Fluorouracil Plus Interferon Alfa in Treating Patients With Advanced Metastatic Carcinoid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT00454376 -
Disease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors
|
Phase 4 | |
| Terminated |
NCT00002947 -
Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer
|
Phase 1 | |
| Completed |
NCT00427349 -
AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors
|
Phase 2 | |
| Completed |
NCT00416767 -
Combination Chemotherapy as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors of the Duodenum or Pancreas That Cannot Be Removed By Surgery
|
Phase 2 | |
| Completed |
NCT00005049 -
Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer
|
Phase 2 | |
| Completed |
NCT00027638 -
Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors
|
Phase 2 | |
| Completed |
NCT00019474 -
Combination Chemotherapy Plus Interferon Alfa Followed by Filgrastim in Treating Patients With Gastrointestinal Tract Cancer
|
Phase 2 | |
| Terminated |
NCT00227617 -
Combination Chemotherapy and Bevacizumab in Treating Patients With Advanced Neuroendocrine Tumors
|
Phase 2/Phase 3 | |
| Completed |
NCT00654160 -
Irinotecan, Fluorouracil, and Leucovorin in Treating Patients With Advanced Gastrointestinal Cancer
|
Phase 1 | |
| Completed |
NCT00049023 -
Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors
|
Phase 1 | |
| Completed |
NCT00004911 -
Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction
|
Phase 1/Phase 2 | |
| Completed |
NCT00004910 -
Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction
|
Phase 1/Phase 2 | |
| Completed |
NCT00006368 -
Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT00730483 -
Doxorubicin Beads in Treating Patients With Unresectable Liver Metastases From Neuroendocrine Tumors
|
N/A | |
| Completed |
NCT00602082 -
Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors
|
Phase 2 | |
| Completed |
NCT00017199 -
PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
|
Phase 2 |