Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors

NCT00006485 | Completed Phase 1

• 3 other identifiers: CDR0000068316MSKCC-00091NCI-2272
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use 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 irinotecan in treating patients who have locally advanced or metastatic solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

alvocidib DRUG

irinotecan hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically proven locally advanced or metastatic solid tumor that is refractory to standard therapy or for which no standard therapy exists * Eligible for treatment at the maximum tolerated dose only if disease accessible for tissue biopsy by Tru-Cut, CT guidance, or endoscopy * Pleural effusions or abdominal ascites do not constitute adequate tissue for biopsy * No known CNS metastasis or primary CNS tumor PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 3,500/mm\^3 * Total neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No cardiac arrhythmias, congestive heart failure, or myocardial infarction within the past 6 months Other: * Not pregnant or nursing (during and for at least 2 months after study) * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 2 months after study * No concurrent serious or uncontrolled infection * HIV negative * No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * Prior irinotecan allowed Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered Surgery: * See Disease Characteristics Other: * Recovered from prior therapy * No other concurrent investigational medication * No concurrent vitamins (except a single multivitamin tablet), antioxidants, or herbal preparations or supplements * No concurrent subcutaneous heparin or heparinoids

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

alvocidib; Irinotecan

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Gary K. Schwartz, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 6, 2000
• First Posted: January 27, 2003
• Study Start: September 1, 2000
• Primary Completion: December 1, 2003
• Last Updated: December 15, 2009

Record last verified: 2003-06

Locations

US (1)