Clinical trialPhase 2Completed
Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer
A Phase II Study of Sequential Paclitaxel and Bryostatin-1 for Patients With Advanced Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- March 2002
- Expected end
- April 2010
- Enrollment
- 19 participants
- Sites
- 1
- Primary outcomes
- Response Rate of at Least 30%
- Sponsor
- Nih
- Results posted
- 2015-04-21
- Last update
- 11 June 2021
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Brief summary public domain (ClinicalTrials.gov)
Phase II trial to study the effectiveness of combining paclitaxel and bryostatin-1 in treating patients who have locally advanced unresectable or metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin-1 may help paclitaxel kill more cancer cells by making tumor cells more sensitive to the drug.
Detailed description public domain (ClinicalTrials.gov)
PRIMARY OBJECTIVES: I. To determine the response rates to weekly, sequential paclitaxel/ bryostatin-1 in patients with unresectable and metastatic pancreatic cancer. II. To determine the toxicity of therapy. III. To determine patient survival after therapy. IV. To determine Bryostatin-1 pharmacokinetics. OUTLINE: This is an open-label, multicenter study. Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Response Rate of at Least 30% [Up to 8 years]. Number, participants. Treatment (Paclitaxel, Bryostatin 1) (n=19): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Adverse Events [Up to 8 years]. Count Of Participants, Participants. Treatment (Paclitaxel, Bryostatin 1) (n=19): 10.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [Up to 8 years]. Count Of Participants, Participants. Treatment (Paclitaxel, Bryostatin 1) (n=19): 17.
Papers 1
- Registry-listed results paperPhase II study of paclitaxel plus the protein kinase C inhibitor bryostatin-1 in advanced pancreatic carcinoma. DOI 10.1097/coc.0b013e3181a31920↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.