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Phase 2 Completed N=10 Treatment

Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer

Source: ClinicalTrials.gov NCT00331682 ↗
Enrolled (actual)
10
Serious AEs
100.0%
Results posted
Jan 2014
Primary outcomePrimary: Objective Response Rate as Measured by RECIST Criteria — 3; 6 participants

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 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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Objective Response Rate as Measured by RECIST Criteria
3; 6
SECONDARY
Time to Progression
8
SECONDARY
Overall Survival
4.2

Eligibility Criteria

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00331682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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