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Gemcitabine Plus Flavopiridol in Treating Patients With Advanced Solid Tumors

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00007917
Collaborator
(none)
58
Enrollment
2
Locations
1
Arm
117
Duration (Months)
29
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase I trial to study the effectiveness of gemcitabine plus flavopiridol in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

OBJECTIVES:

  1. Determine the maximum tolerated dose of gemcitabine and flavopiridol in patients with advanced solid tumors.

  2. Determine the toxicity and safety profile of this regimen in these patients.

  3. Determine the pharmacokinetic profile of this regimen in this patient population.

OUTLINE: This is a dose-escalation study.

Patients receive gemcitabine IV over 1-2.5 hours on days 1 and 8 and flavopiridol IV continuously over 24 hours on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gemcitabine and flavopiridol until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 6-58 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Trial Of Gemcitabine Followed By Flavopiridol In Patients With Solid Tumors
Study Start Date :
Jan 1, 2001
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Oct 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I

Patients receive gemcitabine IV over 1-2.5 hours on days 1 and 8 and flavopiridol IV continuously over 24 hours on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine and flavopiridol until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Drug: alvocidib

Drug: gemcitabine hydrochloride

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically proven solid tumor for which gemcitabine is a treatment option or for which no effective therapy exists

    • Previously untreated disease allowed

    • No large and potentially symptomatic pericardial effusion or undrained pleural effusion (with or without pleurodesis)

    • No CNS metastases

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • ECOG 0-2
    Life expectancy:
    • At least 12 weeks
    Hematopoietic:

    • Absolute neutrophil count at least 2,000/mm3

    • Platelet count at least 100,000/mm3

    • No prior thrombotic events

    Hepatic:

    • Bilirubin no greater than 1.5 mg/dL

    • SGOT no greater than 2 times upper limit of normal

    Renal:
    • Creatinine no greater than 1.5 mg/dL
    Cardiovascular:

    • No clinically significant cardiac disease

    • No prior deep venous thrombus

    • No prior arterial vascular event

    • No prior myocardial infarction

    • No unstable angina

    • No prior transient ischemic attack or cerebrovascular accident

    • No cardiac arrhythmias that could be related to cardiac ischemia

    Pulmonary:

    • No clinically significant pulmonary disease

    • No history of pulmonary embolism

    Other:

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • No active infection

    • No severe malnutrition or intractable emesis

    • No chronic diarrheal disease within the past 6 months

    PRIOR CONCURRENT THERAPY:
    Chemotherapy:

    • No more than 1 prior chemotherapy regimen

    • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

    • Prior gemcitabine or flavopiridol allowed

    • No other concurrent chemotherapy

    Radiotherapy:

    • At least 3 weeks since prior radiotherapy and recovered

    • No prior radiotherapy to more than 50% of bone marrow

    • No concurrent radiotherapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    2 Dana-Farber Cancer Institute Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00007917
    Other Study ID Numbers:
    • 00-166
    • U01CA062490
    • P30CA006516
    • DFCI-00166
    • NCI-24
    • CDR0000068344
    First Posted:
    Oct 15, 2003
    Last Update Posted:
    Feb 28, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by National Cancer Institute (NCI)
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Neoplasms
    Gemcitabine
    Alvocidib

    Study Results

    No Results Posted as of Feb 28, 2013