Flavopiridol in Treating Patients With Refractory Cancer

National Cancer Institute (NCI) (NIH)
Overall Status
CT.gov ID

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of flavopiridol in treating patients who have refractory cancer.

Detailed Description

OBJECTIVES: I. Determine the dose-limiting toxicity and maximum tolerated dose of flavopiridol in patients with refractory solid tumors or lymphoma. 2. Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a dose-escalation study. Patients receive flavopiridol IV over 1 hour on day

  1. Treatment continues every 3 weeks in the absence of disease progression. A cohort of 3-6 patients receives treatment at each dose level of flavopiridol. If dose-limiting toxicity (DLT) occurs in no more than 1 of 6 patients, subsequent cohorts of 6 patients each receive escalating doses of drug on the same schedule. Intrapatient dose escalation to the next level is permitted in the absence of DLT.

PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study within 27 months.

Study Design

Study Type:
Primary Purpose:
Official Title:
A Phase I Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With Refractory Neoplasms
Study Start Date :
Aug 1, 1997

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:

    DISEASE CHARACTERISTICS: Histologically proven refractory solid tumor or lymphoma requiring systemic therapy No standard therapeutic options exist Prostate cancer patients: Tumor progression during blockade of testicular and adrenal androgen required PSA elevation on 2 consecutive blood samples, 2 weeks apart Serum testosterone concentrations in the castrate range Leuprolide or other gonadotropin-releasing hormone (GnRH) analogs maintained if no prior orchiectomy No CNS neoplasms

    PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 75,000/mm3 Absolute granulocyte count at least 1,000/mm3 No active coagulopathy requiring therapeutic anticoagulation Hepatic: SGOT and SGPT no greater than 2.5 times normal Bilirubin no greater than 1.5 times normal (3 times normal if Gilbert's disease present) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of unstable or newly diagnosed angina pectoris No myocardial infarction within past 6 months No New York Heart Association class II-IV heart disease Other: No serious concurrent medical illness HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study

    PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No prior flavopiridol Endocrine therapy: See Disease Characteristics A least 4 weeks since prior flutamide or other antiandrogen therapy without disease improvement At least 4 weeks since prior hormonal therapy for breast carcinoma and must show evidence of disease progression No concurrent corticosteroids except for physiological replacement Radiotherapy: At least 4 weeks since prior radiotherapy and recovered At least 6 weeks since prior bone-seeking radioisotope therapy Surgery: Not specified Other: At least 3 months since prior suramin treatment At least 2 months since prior UCN-01 No concurrent anticoagulation therapy No other concurrent antineoplastic therapy except for GnRH for prostate cancer

    Contacts and Locations


    Site City State Country Postal Code
    1 Medicine Branch Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Cancer Institute (NCI)


    • Study Chair: Edward A. Sausville, MD, PhD, National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • CDR0000065779
    • NCI-97-C-0171C
    • NCI-T97-0064
    • NCT00001585
    First Posted:
    Apr 21, 2004
    Last Update Posted:
    Apr 29, 2015
    Last Verified:
    May 1, 2002
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 29, 2015