Clinical trialPhase 2Terminated
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
- Outcome
- Stopped early. Results posted; no primary outcome with dataDevelopment of new chemotherapy standard of care for treatment rendered the trial obsolete. (Other)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- August 2007
- Ended
- March 2008
- Enrollment
- 1 participants
- Sites
- 1
- Primary outcomes
- Number of Participants With Progression Free Survival (PFS) at 12 Months
- Sponsor type
- Academic / other
- Results posted
- 22 March 2011
- Last update
- 23 March 2017
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; no primary outcome with dataAs posted on ClinicalTrials.gov ↗, registry record of 23 March 2017
- Primary outcome, no data
- Number of Participants With Progression Free Survival (PFS) at 12 MonthsThe registry’s note: Per protocol at 12 months
- Participants
- Chemotherapy: 1 started, 0 completed
- Serious adverse events
- Chemotherapy: 0 of 1Participants with at least one serious adverse event, of those at risk, as posted
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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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Progression Free Survival (PFS) at 12 Months [12 months].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
The Number of Participants With Radiographic Response [2 years].