Clinical trialPhase 2Completed
Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer
An Open-Label, Non-Randomized Phase II Study of Alvocidib (Flavopiridol) in Combination With Docetaxel in Refractory, Metastatic Pancreatic Cancer (NCI #6366)
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- March 2006
- Expected end
- May 2008
- Enrollment
- 10 participants
- Sites
- 1
- Primary outcomes
- Objective Response Rate as Measured by RECIST Criteria
- Sponsor
- Nih
- Results posted
- 2014-01-10
- Last update
- 28 May 2014
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Brief summary public domain (ClinicalTrials.gov)
Drugs used in chemotherapy, such as docetaxel and flavopiridol, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Flavopiridol may also help docetaxel work better by making tumor cells more sensitive to the drug. This phase II trial is studying how well giving docetaxel followed by flavopiridol works in treating patients with refractory metastatic pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
PRIMARY OBJECTIVES: I. Determine the response rate in patients with refractory, metastatic pancreatic cancer treated with weekly, sequential docetaxel and flavopiridol. SECONDARY OBJECTIVES: I. Determine the time to progression and overall survival of patients treated with this regimen. II. Assess the toxicity of this regimen. OUTLINE: This is a non-randomized, open-label, prospective study. Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Objective Response Rate as Measured by RECIST Criteria [Up to 2 years]. Number, participants. Stable Disease: Docetaxel and Flavopiridol (n=9): 3. Progression of Disease: Docetaxel and Flavopiridol (n=9): 6.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to Progression [Between the start of treatment until the criteria for progression are met, assessed up to 2 years]. Median, weeks (Full Range). Docetaxel and Flavopiridol (n=9): 8 (7 to 14).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [Between the start of treatment until patient death, assessed up to 2 years]. Median, months (Full Range). Docetaxel and Flavopiridol (n=9): 4.2 (2.8 to 6.9).