BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer

NCT ID: NCT00006086

Last Updated: 2010-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-06-30

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 BMS-188797 and carboplatin in treating patients who have advanced nonhematologic cancer.

Detailed Description

OBJECTIVES:

• Determine the recommended phase II dose based on the maximum tolerated dose of BMS-188797 when administered with carboplatin in patients with advanced nonhematologic malignancies.
• Assess the dose limiting toxicities and safety of this treatment regimen in these patients.
• Determine the plasma pharmacokinetics of this treatment regimen in these patients.
• Determine any antitumor activity of this treatment regimen in these patients.

OUTLINE: This is a dose escalation study of BMS-188797.

Patients receive BMS-188797 IV over 1 hour followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BMS-188797 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities.

Patients are followed for 4 weeks, and then every 3 months thereafter.

PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study over 12 months.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

BMS-188797

Intervention Type: DRUG

carboplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed advanced nonhematologic malignancy that has progressed on standard therapy or for which no curative therapy exists
• No brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute 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
• ALT and AST no greater than 2.5 times upper limit of normal (ULN) unless due to hepatic metastases

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• No chronic medical condition requiring treatment with corticosteroids
• No prior severe hypersensitivity reaction to agents containing Cremophor (polyoxyethylated castor oil)
• No serious uncontrolled medical disorder, active infection, or psychiatric disorder (e.g., dementia) that would preclude study
• No preexisting neurotoxicity grade 1 or greater
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered
• No concurrent immunotherapy

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• No more than 2 prior chemotherapy regimens for metastatic disease
• No prior platinum or taxane therapy
• No other concurrent chemotherapy

Endocrine therapy:

• At least 2 weeks since prior hormonal therapy (except megestrol for anorexia/cachexia) and recovered
• At least 7 days since prior corticosteroids
• No concurrent corticosteroids
• No concurrent hormonal therapy

Radiotherapy:

• At least 4 weeks since prior radiotherapy to 30% or more of bone marrow and recovered
• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• No other concurrent investigational drug

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Principal Investigators

Daniel M. Sullivan, MD

Role: STUDY_CHAIR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

References

Fishman MN, Garrett CR, Simon GR, Chiappori AA, Lush RM, Dinwoodie WR, Mahany JJ, Dellaportas AM, Cantor A, Gollerki A, Cohen MB, Sullivan DM. Phase I study of the taxane BMS-188797 in combination with carboplatin administered every 3 weeks in patients with solid malignancies. Clin Cancer Res. 2006 Jan 15;12(2):523-8. doi: 10.1158/1078-0432.CCR-05-0928.

Reference Type: RESULT

PMID: 16428495 (View on PubMed)

Other Identifiers

MCC-12176

Identifier Type: -

Identifier Source: secondary_id

BMS-CA159-003

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1825

Identifier Type: -

Identifier Source: secondary_id

CDR0000068078

Identifier Type: -

Identifier Source: org_study_id