RATIONALE: 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.

PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol with gemcitabine and irinotecan in treating patients who have unresectable or metastatic solid tumors.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Drug: flavopiridol  Drug: gemcitabine  Drug: irinotecan  Procedure: chemotherapy	Phase I

Further Study Details: 

OBJECTIVES: Primary

• 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.
• 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 8. Patients also receive flavopiridol IV over 60 minutes on days 2 and 9. Treatment repeats every 21 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.

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

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/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

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

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

New Mexico
      University of New Mexico Cancer Research and Treatment Center, Albuquerque,  New Mexico,  87131-5636,  United States; Recruiting

Study chairs or principal investigators

Ian Rabinowitz, MD,  Study Chair,  University of New Mexico   

Study ID Numbers:  CDR0000355358; UNM-0903C; NCI-6415; NCT00079352
Record last reviewed:  August 2004
Last Updated:  December 6, 2004
Record first received:  March 8, 2004
ClinicalTrials.gov Identifier:  NCT00079352
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08