Clinical trialPhase 2 / Phase 3Terminated
Combination Chemotherapy and Bevacizumab in Treating Patients With Advanced Neuroendocrine Tumors
A Pilot Study of FOLFOX in Combination With Bevacizumab in Patients With Advanced Neuroendocrine Tumors
- Outcome
- Stopped early. Results posted; single-arm, no comparisonLow accrual (Enrollment)
- Phase
- Phase 2 / Phase 3
- Status
- Terminated
- Study type
- Interventional
- Start
- 8 June 2005
- Ended
- February 2016
- Enrollment
- 36 participants
- Sites
- 2
- Primary outcomes
- Rate of Discontinuation Due to Adverse Events Possibly Related to Study Treatment; Best Objective Response
- Sponsor type
- Academic / other
- Results posted
- 26 December 2019
- Last update
- 22 May 2023
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
Results
- Primary endpoint
- Results posted; single-arm, no comparisonAs posted on ClinicalTrials.gov ↗, registry record of 22 May 2023
- Primary outcome
- Rate of Discontinuation Due to Adverse Events Possibly Related to Study TreatmentCarcinoid: 3 of 22PNET: 3 of 12PDNEC: 0 of 2Values: ParticipantsTime frame: From beginning of treatment up to 18 months; Post-study survival follow-up up to 8 yearsNo analysis posted for this outcome (outcome 1)
- ORR
- Best Objective ResponseUnevaluable: Combined Neuroendocrine Tumors: 2.8 (0 to 14), n = 36Progressive Disease: Combined Neuroendocrine Tumors: 2.8 (0 to 14), n = 36Partial Response: Combined Neuroendocrine Tumors: 31 (16 to 48), n = 36Stable Disease: Combined Neuroendocrine Tumors: 64 (46 to 79), n = 36Values: percentage of participants, 95% Confidence IntervalTime frame: From Baseline until disease progression, up to 8 yearsNo analysis posted for this outcome (outcome 2)
- Participants
- Carcinoid: 22 started, 0 completedPNET: 12 started, 0 completedPoorly Differentiated Neuroendocrine Carcinomas (PDNEC): 2 started, 0 completed
- Serious adverse events
- Combined Neuroendocrine Tumors: 12 of 36Participants with at least one serious adverse event, of those at risk, as posted
4 secondary outcomes
- Time to Progression
- Carcinoid 19.3 (9.9 to 29.9), n=22; PNET 21 (7.4 to 31.4), n=12 [median months, 95% Confidence Interval]
- Overall Median Survival
- Combined Neuroendocrine Tumors 31.0 (23.3 to 34.5), n=36 [median months, 95% Confidence Interval]
- Overall Time to Treatment Failure
- Combined Neuroendocrine Tumors 9.1 (6.5 to 13.8), n=36 [median months, 95% Confidence Interval]
- Biochemical Marker Response
- Chromogranin A (CGA): Carcinoid 25, n=13; PNET 78, n=10; PDNEC 0, n=2; All Neuroendocrine Tumors 50, n=23 [percentage of participants] (first of 3 rows)
Every value is copied from the trial’s results record at ClinicalTrials.gov. “Statistically significant” describes the posted test only: it does not say which group did better, and nothing here is read from a paper.
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Source text
Brief summary public domain (ClinicalTrials.gov)
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of neuroendocrine tumors by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects of giving combination chemotherapy together with bevacizumab and to see how well it works in treating patients with advanced neuroendocrine tumors.
Detailed description public domain (ClinicalTrials.gov)
OBJECTIVES: Primary * Determine the safety of fluorouracil, leucovorin calcium, and oxaliplatin (FOLFOX) with bevacizumab in patients with advanced neuroendocrine tumors. * Determine the best overall response rate in patients treated with this regimen. Secondary * Determine the overall survival of patients treated with this regimen. * Determine the time to treatment failure and progression in patients treated with this regimen. * Determine the biochemical marker response in patients treated with this regimen. OUTLINE: This is an open-label, pilot study. Patients are stratified according to tumor type (carcinoid vs islet cell vs poorly differentiated neuroendocrine). Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours beginning on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 39-102 patients (13-34 per stratum) will be accrued for this study.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Rate of Discontinuation Due to Adverse Events Possibly Related to Study Treatment [From beginning of treatment up to 18 months; Post-study survival follow-up up to 8 years]. Count Of Participants, Participants. Carcinoid (n=22): 3; PNET (n=12): 3; PDNEC (n=2): 0.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Best Objective Response [From Baseline until disease progression, up to 8 years]. Number, percentage of participants (95% Confidence Interval). Unevaluable: Combined Neuroendocrine Tumors (n=36): 2.8 (0 to 14). Progressive Disease: Combined Neuroendocrine Tumors (n=36): 2.8 (0 to 14). Partial Response: Combined Neuroendocrine Tumors (n=36): 31 (16 to 48). Stable Disease: Combined Neuroendocrine Tumors (n=36): 64 (46 to 79).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to Progression [From beginning of treatment up to 18 months; Post-study survival follow-up up to 8 years]. Median, months (95% Confidence Interval). Carcinoid (n=22): 19.3 (9.9 to 29.9); PNET (n=12): 21 (7.4 to 31.4).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Median Survival [until death, up to 8 years]. Median, months (95% Confidence Interval). Combined Neuroendocrine Tumors (n=36): 31.0 (23.3 to 34.5).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Time to Treatment Failure [From initial complete or partial response to disease progression, up to 8 years]. Median, months (95% Confidence Interval). Combined Neuroendocrine Tumors (n=36): 9.1 (6.5 to 13.8).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Biochemical Marker Response [From Baseline until end of treatment, up to 8 years]. Number, percentage of participants. Chromogranin A (CGA): Carcinoid (n=13): 25; PNET (n=10): 78; PDNEC (n=2): 0; All Neuroendocrine Tumors (n=23): 50. Any hormone and/or CGA: Carcinoid (n=13): 31; PNET (n=10): 80; PDNEC (n=2): 0; All Neuroendocrine Tumors (n=23): 52. Any hormone (not including CGA): Carcinoid (n=13): 23; PNET (n=10): 60; PDNEC (n=2): 0; All Neuroendocrine Tumors (n=23): 33.