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Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00079352
Collaborator
(none)
24
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

This phase I trial is studying the side effects and best dose of flavopiridol when given together with gemcitabine and irinotecan in treating patients with unresectable or metastatic solid tumors. Drugs used in chemotherapy, such as flavopiridol, gemcitabine, and irinotecan, work in 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
  • Drug: alvocidib
  • Drug: gemcitabine hydrochloride
  • Drug: irinotecan hydrochloride
 Phase 1

Detailed Description

PRIMARY OBJECTIVES:

  1. Determine the maximum tolerated dose and recommended phase II dose of flavopiridol in combination with gemcitabine and irinotecan in patients with unresectable or metastatic solid tumors.

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

OUTLINE: This is a dose-escalation study of flavopiridol.

Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 15. Patients also receive flavopiridol IV over 60 minutes on days 2 and 16. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Study of Flavopiridol in Combination With Gemcitabine and Irinotecan in Patients With Metastatic Cancer
Study Start Date :
Apr 1, 2004
Actual Primary Completion Date :
Oct 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (gemcitabine, irinotecan, alvocidib)

Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 15. Patients also receive flavopiridol IV over 60 minutes on days 2 and 16. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: alvocidib
Given IV
Other Names:
  • FLAVO
  • flavopiridol
  • HMR 1275
  • L-868275

    • Drug: gemcitabine hydrochloride
    Given IV
    Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar

    • Drug: irinotecan hydrochloride
    Given IV
    Other Names:
  • Campto
  • Camptosar
  • CPT-11
  • irinotecan
  • U-101440E

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Recommended phase II dose of flavopiridol defined as the highest dose for which no more than one patient develop a >= grade 3 toxicity [28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically confirmed solid tumor that is metastatic or unresectable

    • Standard curative or palliative measures do not exist or are no longer effective

    • No known brain metastases

    • Performance status - ECOG 0-2

    • Performance status - Karnofsky 60-100%

    • More than 12 weeks

    • WBC ≥ 3,000/mm^3

    • Absolute neutrophil count ≥ 1,500/mm^3

    • Platelet count ≥ 100,000/mm^3

    • Bilirubin normal

    • AST and ALT ≤ 2.5 times upper limit of normal

    • Creatinine normal

    • Creatinine clearance ≥ 60 mL/min

    • No venous thrombosis within the past 6 months

    • No thrombotic cerebrovascular accident within the past 6 months

    • No myocardial infarction within the past 6 months

    • No symptomatic congestive heart failure

    • No unstable angina pectoris

    • No cardiac arrhythmia

    • No ongoing or active infection

    • No prior allergic reaction attributed to compounds of similar chemical or biological composition to study agents

    • No other concurrent uncontrolled medical condition that would preclude study participation

    • No psychiatric illness or social situation that would preclude study participation

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • Prior biologic therapy allowed

    • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

    • Prior endocrine therapy allowed

    • More than 4 weeks since prior radiotherapy and recovered

    • Prior surgery allowed

    • No other concurrent investigational agents

    • No concurrent combination antiretroviral therapy for HIV-positive patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of New Mexico Albuquerque New Mexico United States 87106

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Ian Rabinowitz, University of New Mexico

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00079352
    Other Study ID Numbers:
    • NCI-2012-02580
    • UNM-0903C
    • CDR0000355358
    First Posted:
    Mar 10, 2004
    Last Update Posted:
    Jan 25, 2013
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:
    Gemcitabine
    Irinotecan
    Alvocidib

    Study Results

    No Results Posted as of Jan 25, 2013