Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors

NCT ID: NCT00003004

Last Updated: 2013-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-07-31
• Study Completion Date: 2001-10-31

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 combination chemotherapy with paclitaxel and cisplatin plus flavopiridol in treating patients who have refractory or recurrent solid tumors.

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of flavopiridol when administered in combination with paclitaxel and cisplatin in patients with refractory adult solid tumors. II. Investigate the clinical pharmacokinetics of intravenous flavopiridol when administered in combination with paclitaxel in these patients. III. Obtain preliminary data on the therapeutic activity of flavopiridol when administered in combination with paclitaxel in these patients. IV. Evaluate surrogate markers of activity such as inhibition of PKC or CDK1 in these patients.

OUTLINE: This is an open label, dose escalation study. Patients receive paclitaxel IV over 3 hours on day 1. On day 2, patients receive cisplatin IV over 20 minutes followed by a 24 hour infusion of flavopiridol. Courses are repeated every 21 days in the absence of disease progression or unacceptable toxicity. Sequential dose escalation of flavopiridol is followed by sequential dose escalation of cisplatin. Dose escalation in cohorts of 3-6 patients each continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed every 6 weeks.

PROJECTED ACCRUAL: Approximately 46-73 patients will be accrued for this study within 6 more months.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

alvocidib

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven solid tumors that are refractory or recurrent -No CNS primary or metastatic disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky at least 60% Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST and ALT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: At least 6 months since prior cardiac arrhythmias, myocardial infarction, or congestive heart failure Other: Not pregnant or nursing Effective contraceptive method must be used for 2 months after study completion Not HIV positive No uncontrolled or serious infection No pre-existing grade 3 or greater neurotoxicity Must be mentally capable of understanding the explanation of the study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified Other: No presence of toxic effects from prior therapy

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Gary K. Schwartz, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

CDR0000065571

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-T96-0091

Identifier Type: -

Identifier Source: secondary_id

96-077

Identifier Type: -

Identifier Source: org_study_id