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An Open-Label, Non-Randomized Phase II Study of Alvocidib (Flavopiridol) in Combination With Docetaxel in Refractory, Metastatic Pancreatic Cancer (NCI #6366)

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer

Thank you

Trial Information

An Open-Label, Non-Randomized Phase II Study of Alvocidib (Flavopiridol) in Combination With Docetaxel in Refractory, Metastatic Pancreatic Cancer (NCI #6366)


I. Determine the response rate in patients with refractory, metastatic pancreatic cancer
treated with weekly, sequential docetaxel and flavopiridol.


I. Determine the time to progression and overall survival of patients treated with this

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.

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

- 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

- 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

- 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

- Single-tablet multivitamin allowed

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate as measured by RECIST criteria

Outcome Time Frame:

Up to 2 years

Safety Issue:


Principal Investigator

Eileen O'Reilly

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021