Status:
COMPLETED
Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 tha...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the response rate in patients with refractory, metastatic pancreatic cancer treated with weekly, sequential docetaxel and flavopiridol. SECONDARY OBJECTIVES: I. Det...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Evidence of metastatic disease
- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20mm with conventional techniques or as ≥ 10 mm with spiral CT scan
- The primary site is not a measurable lesion
- Documented progression with measurable metastatic disease including any 1 of the following criteria:
- Receiving adjuvant therapy for resected disease
- Receiving therapy for locally advanced disease
- Within 3 months of completing adjuvant therapy or therapy for locally advanced disease
- On 1 prior regimen in the metastatic setting
- No documented brain metastases
- Karnofsky performance status (PS) 80-100% OR ECOG PS 0-1
- WBC ≥ 2,500/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT \< 2.5 times ULN
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Alkaline phosphatase ≤ 5 times ULN
- No history of allergic reactions to compounds of similar chemical orbiological composition to flavopiridol
- No known allergy to docetaxel or medications formulated in polysorbate 80 (Tween 80)
- No uncontrolled diabetes
- No uncontrolled intercurrent illness including, but not limited to any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia or myocardial infarction within the past 6 months
- Rate-controlled atrial fibrillation stable for ≥ 6 months allowed
- Psychiatric illness or social situations that would limit compliance with study requirements
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No peripheral neuropathy \> grade 1
- No immune deficiency
- Atl east 2 weeks since prior chemotherapy (6 weeks for nitrosoureas, carmustine, or mitomycin C) and recovered
- At least 2 weeks since prior targeted therapy (e.g., antiangiogenic therapy \[e.g., bevacizumab\] or epidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[e.g., erlotinib hydrochloride\]) and recovered
- At least 4 weeks since prior radiation therapy
- No prior docetaxel or flavopiridol
- No other concurrent chemotherapy or investigational agents
- No other concurrent anticancer agents or therapies
- No concurrent commonly used vitamins, antioxidants, orherbal preparations or supplements
- Single-tablet multivitamin allowed
- No concurrent combination antiretroviral therapy for HIV-positive patients
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00331682
Start Date
March 1 2006
End Date
May 1 2008
Last Update
May 28 2014
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065