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

Phase I Study of BMS-188797 in Combination With Carboplatin in Patients With Advanced Malignancies

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.

Study Overview

• Status: Completed
• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Intervention / Treatment: Drug: carboplatin; Drug: BMS-188797

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.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612-9497
      • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Daniel M. Sullivan, MD, H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2000
• Primary Completion (Actual): February 1, 2003

Study Registration Dates

• First Submitted: August 3, 2000
• First Submitted That Met QC Criteria: May 21, 2003
• First Posted (Estimate): May 22, 2003

Study Record Updates

• Last Update Posted (Estimate): September 9, 2010
• Last Update Submitted That Met QC Criteria: September 8, 2010
• Last Verified: September 1, 2002

More Information

Terms related to this study

• Keywords: unspecified adult solid tumor, protocol specific
• Additional Relevant MeSH Terms: Antineoplastic Agents; Carboplatin
• Other Study ID Numbers: CDR0000068078; MCC-12176; BMS-CA159-003; NCI-G00-1825