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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
N/A
Not Enrolling
Both
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

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:

No

Principal Investigator

Eileen O'Reilly

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01471

NCT ID:

NCT00331682

Start Date:

March 2006

Completion Date:

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021