Flavopiridol in Treating Patients With Refractory Cancer

NCT ID: NCT00019344

Last Updated: 2015-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-08-31

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.

Conditions

Lymphoma; Prostate Cancer; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

alvocidib

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Edward A. Sausville, MD, PhD

Role: STUDY_CHAIR

National Cancer Institute (NCI)

Locations

Medicine Branch

Bethesda, Maryland, United States

Countries

United States

References

Senderowicz AM, Messmann R, Arbuck S, et al.: A phase I trial of 1 hour infusion of flavopiridol (FLA), a novel cyclin-dependent Kinase inhibitor, in patients with advanced neoplasms. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A-796, 2000.

Reference Type: RESULT

Other Identifiers

NCI-97-C-0171C

Identifier Type: -

Identifier Source: secondary_id

NCI-T97-0064

Identifier Type: -

Identifier Source: secondary_id

CDR0000065779

Identifier Type: -

Identifier Source: org_study_id

NCT00001585

Identifier Type: -

Identifier Source: nct_alias