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Active, not recruiting Phase 3

Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor

NCT00569127 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2007-12-01
Last updated
2026-10-22

Condition(s) studied

Colorectal Neuroendocrine Tumor G1Gastric Neuroendocrine Tumor G1Neuroendocrine NeoplasmNeuroendocrine TumorNeuroendocrine Tumor G2

Investigational drug(s) / intervention(s)

Bevacizumab →Laboratory Biomarker AnalysisOctreotide Acetate →Recombinant Interferon Alfa-2b →

Bevacizumab: Given IV

Laboratory Biomarker Analysis: Correlative studies

Octreotide Acetate: Given IM

Recombinant Interferon Alfa-2b: Given SC

Study summary

This randomized phase III trial studies octreotide acetate and recombinant interferon alfa-2b to see how well it works compared to octreotide acetate and bevacizumab in treating patients with high-risk neuroendocrine tumors that have spread to other places in the body (metastatic) or spread from where it started to nearby tissue or lymph nodes (locally advanced). Octreotide acetate and recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of cancer. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving octreotide acetate together with recombinant interferon alfa-2b is more effective than giving octreotide acetate together with bevacizumab in treating patients with neuroendocrine tumor.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient must have unresectable metastatic or locally advanced, low- or intermediate-grade neuroendocrine carcinoma * NOTE: pathology report must state one of the following: carcinoid, low-grade or well-differentiated neuroendocrine carcinoma, atypical carcinoid, intermediate-grade or moderately differentiated neuroendocrine carcinoma; patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, or goblet cell carcinoid are not eligible; patient must not have osseous metastasis as only site of disease; patients with medullary thyroid carcinoma or islet cell carcinoma are not eligible; if pathology report states only neuroendocrine carcinoma, pathology subtype must be reconfirmed * Occasionally, it is not possible to establish tumor grade on fine-needle aspiration (FNA) cytology material; if a new biopsy is needed, a core needle biopsy should be obtained whenever possible * Patient must have high risk disease as defined by at least one of the following: * Progressive disease * Refractory carcinoid syndrome while receiving octreotide (defined by \> 2 flushing episodes/day or \> 4 bowel movements/day) * Atypical histology and more than 6 lesions * Metastatic colorectal carcinoid; patients with metastatic cecal or appendiceal carcinoid tumor are not eligible unless the tumors fit into one of the other high-risk categories (a, b, or c above) * Metastatic gastric carcinoid * Patient must have measurable disease; CT or magnetic resonance imaging (MRI) used for tumor measurement must have been completed within 28 days prior to registration; X-rays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form; these scans also must be submitted for central radiology review * Institutions are required to submit CT/MRI scans and archived tissue for pathology review; furthermore, institutions are required to seek additional patient consent for submission of octreotide scans, and submission of blood and use of archived tissue for correlative studies * If patient consents to the submission of octreotide scans, the patient must also be registered to Registration Step 2 * Patient may have had up to one prior regimen of cytotoxic chemotherapy; at least 28 days must have elapsed since completion of prior therapy, and patient must have recovered from all effects * Patient may have had prior hepatic artery embolization; at least 28 days must have elapsed since embolization and there must be residual measurable disease; chemoembolization will be considered as one prior chemotherapy regimen * Patient must not have received prior interferon, bevacizumab or any other therapy targeting VEGF or VEGF receptors * Patient may have received prior therapy targeting stem cell factor receptor (c-kit), abelson murine leukemia viral oncogene homolog 1 (abl), platelet-derived growth factor receptor (PDGFR), mammalian target of rapamycin (mTOR), and somatostatin receptors (not counted toward prior cytotoxic chemotherapy) * Prior radiation is allowed; there must be measurable disease; if prior therapies include peptide receptor radiotherapy, the target lesion(s) must have shown disease progression; at least 28 days must have elapsed since completion of prior therapy, and patient must have recovered from all effects * Patients must have recovered from any prior surgery; one week must have elapsed from the time of a minor surgery and 4 weeks from major surgery * At least 21 days must have elapsed since any prior octreotide LAR depot treatment * Patient must have a Zubrod performance status of 0-2 * Absolute neutrophil count (ANC) \> 1,500/mcl * Hemoglobin \> 8 g/dl * Platelets \> 100,000/mcl * Serum bilirubin \< 1.5 x institutional upper limit of normal (IULN) * Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) =\< 2.5 x IULN * Serum creatinine \< 1.5 mg/dL * Urine protein must be screened by urine analysis for Urine Protein Creatinine (UPC) ratio; for UPC ratio \> 0.5, 24-hour urine protein must be obtained and the level must be \< 1,000 mg for patient enrollment; these results must be obtained within 28 days prior to registration * Note: UPC ratio of spot urine is an estimation of the 24-hour urine protein excretion - a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm * Patients not on anticoagulation must have prothrombin time (PT) and partial thromboplastin time (PTT) =\< 1.1 x lULN obtained within 28 days prior to registration; patients on full-dose anticoagulation (warfarin or low molecular weight heparin) are eligible provided that both of the following criteria are met: * The patient has an in-range international normalized ratio (INR) (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin * The patient has no active bleeding or pathological condition that carries a high risk of bleeding such as varices * Patient must not have history or evidence of clinically significant peripheral vascular disease such as non-healing peripheral ulcers or claudication * Patient must not have a history of primary brain tumor or metastatic cancer to the brain; brain imaging studies are not required for eligibility if the patient has no neurological signs or symptoms; if brain imaging studies are performed, they must be negative for disease * Patient must not have a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to registration * Patient must not have history within the past 5 years or presence of bleeding diathesis or coagulopathy that results in spontaneous bleeding (in the absence of trauma) requiring packed red blood cells (pRBC) transfusion * Patient must not have a serious (requiring active medical therapy with medication or medical device under the supervision of a physician) non-healing wound, ulcer, or bone fracture * Patient must not have recent history (within 6 months prior to registration) of these arterial thromboembolic events: transient ischemic attack, cerebrovascular accident, unstable angina, myocardial infarction, or New York Heart Association grade II or higher congestive heart failure * Patients with a history of hypertension must be well-controlled (blood pressure \< 150/90), on a stable regimen of antihypertensive therapy * Patient must not have hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia * Patient must not plan to use any other concurrent chemotherapy, immunotherapy, hepatic artery embolization, hepatic artery chemoembolization, radiofrequency ablation, other tumor ablative procedure or radiotherapy while on protocol treatment * Patient must not be pregnant or nursing because bevacizumab may be harmful to the developing fetus and newborn; male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout protocol treatment and for up to 6 months following discontinuation of bevacizumab * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for five years * All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional re view board approval for this study has been entered into the data base * REGISTRATION STEP 2 - SPECT SUBSTUDY * Patient must have registered to the main study * Patient must have consented to the submission of octreotide scans * An octreotide scan obtained within 28 days prior to Registration Step 1 must be available for submission

Primary outcome measure(s)

  • Central Review-based Progression-Free Survival — Up to 3 years
    From date of randomization (which is the date of registration) to date of first documentation of progression based on Central Radiological Review of the appropriate CT or MRI scans, or symptomatic deterioration (as defined in Section 10.2e)), or development of new lesions or disease not identified on CT or MRI, or death due to any cause. Patients who have a local assessment of progression based on imaging, but for whom central review does not concur, will be censored at the last Central Radiological Review date, unless subsequent scans or documentation of symptomatic deterioration provides evidence of progression. Patients last known not to have progressed are censored at the date of last contact. Patients with incomplete Central Radiological Review are censored at the date of last Central Radiological Review if patient has not progressed prior to that time.

Trial sites (493)

FacilityCityRegionStatus
Providence Hospital Mobile Alabama
Fairbanks Memorial Hospital Fairbanks Alaska
Mercy Hospital Fort Smith Fort Smith Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
University of Arkansas for Medical Sciences Little Rock Arkansas
Highlands Oncology Group - Rogers Rogers Arkansas
Kaiser Permanente-Anaheim Anaheim California
Arroyo Grande Community Arroyo Grande California
PCR Oncology Arroyo Grande California
Kaiser Permanente-Baldwin Park Baldwin Park California
Kaiser Permanente-Bellflower Bellflower California
Alta Bates Summit Medical Center-Herrick Campus Berkeley California
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
Mills-Peninsula Medical Center Burlingame California
Kaiser Permanente-Fontana Fontana California
Marin General Hospital Greenbrae California
Kaiser Permanente South Bay Harbor City California
Kaiser Permanente-Irvine Irvine California
Kaiser Permanente Los Angeles Medical Center Los Angeles California
Los Angeles General Medical Center Los Angeles California
USC / Norris Comprehensive Cancer Center Los Angeles California
Kaiser Permanente West Los Angeles Los Angeles California
Cedars-Sinai Medical Center Los Angeles California
Sutter Cancer Research Consortium Novato California
Stanford Cancer Institute Palo Alto Palo Alto California
Kaiser Permanente - Panorama City Panorama City California
Kaiser Permanente-Riverside Riverside California
Kaiser Permanente-Rio San Diego San Diego California
Kaiser Permanente-San Diego Zion San Diego California
California Pacific Medical Center-Pacific Campus San Francisco California
Kaiser Permanente-San Marcos San Marcos California
Sutter Pacific Medical Foundation Santa Rosa California
Sutter Solano Medical Center/Cancer Center Vallejo California
Kaiser Permanente-Woodland Hills Woodland Hills California
San Luis Valley Regional Medical Center Alamosa Colorado
The Medical Center of Aurora Aurora Colorado
Rocky Mountain Regional VA Medical Center Aurora Colorado
UCHealth University of Colorado Hospital Aurora Colorado
Boulder Community Foothills Hospital Boulder Colorado
Penrose-Saint Francis Healthcare Colorado Springs Colorado

+ 453 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00569127 on ClinicalTrials.gov ↗ ← All trials in Mexico