Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	UNM-0903C NCI-6415, 6415, NCT00079352

Objectives

Primary

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.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy

• Prior biologic therapy allowed

Chemotherapy

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

Endocrine therapy

• Prior endocrine therapy allowed

Radiotherapy

• More than 4 weeks since prior radiotherapy and recovered

Surgery

• Prior surgery allowed

Other

• No other concurrent investigational agents
• No concurrent combination antiretroviral therapy for HIV-positive patients

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

  OR

• Karnofsky 60-100%

Life expectancy

• More than 12 weeks

Hematopoietic

• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

Hepatic

• Bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal

Renal

• Creatinine normal

  OR

• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• 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

Other

• 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

Expected Enrollment

A total of 3-24 patients will be accrued for this study within 8-12 months.

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.

Rabinowitz I, Verschraegen CF, Lee FC, et al.: A phase 1 study of flavopiridol in combination with gemcitabine and irinotecan in patients with metastatic cancer. [Abstract] J Clin Oncol 24 (Suppl 18): A-13099, 609s, 2006.

Trial Contact Information

Trial Lead Organizations

University of New Mexico Cancer Center

Ian Rabinowitz, MD, Protocol chair		Ph: 505-272-4551 Email: irabinowitz@salud.unm.edu

Registry Information
Official Title		A Phase I Study of Flavopiridol in Combination With Gemcitabine and Irinotecan in Patients With Metastatic Cancer
Trial Start Date		2004-03-23
Trial Completion Date		2007-10-01
Registered in ClinicalTrials.gov		NCT00079352
Date Submitted to PDQ		2004-02-02
Information Last Verified		2007-06-13

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