Paclitaxel and BMS-214662 in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00006018
First received: July 5, 2000
Last updated: June 10, 2010
Last verified: June 2010
  Purpose

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 paclitaxel and BMS-214662 in treating patients who have advanced solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: BMS-214662
Drug: paclitaxel
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of BMS-214662 and Paclitaxel in Patients With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Determine the maximum tolerated dose of BMS-214662 in combination with paclitaxel. [ Time Frame: Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: July 2000
Study Completion Date: April 2002
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: BMS-214662
    This is a dose-escalation study of BMS-214662. BMS-214662 IV over 1 hour on day 3 of course 1. For all subsequent courses, patients receive BMS-214662 IV over 1 hour on day 1 (30 minutes after paclitaxel). Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
    Drug: paclitaxel
    Patients receive paclitaxel IV over 3 hours on day 1 of course 1. For all subsequent courses, patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of BMS-214662 in combination with paclitaxel in patients with advanced solid tumors. II. Determine the safety and tolerability of this regimen in these patients. III. Determine the pharmacokinetics of this treatment regimen in this patient population. IV. Determine the pharmacodynamic effects of this treatment regimen in serial tumor biopsies in these patients. V. Determine the cytotoxicity of this treatment regimen in these patients.

OUTLINE: This is a dose-escalation study of BMS-214662. Patients receive paclitaxel IV over 3 hours on day 1 and BMS-214662 IV over 1 hour on day 3 of course 1. For all subsequent courses, patients receive paclitaxel IV over 3 hours followed 30 minutes later by BMS-214662 IV over 1 hour on day 1. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or objectively responding disease receive additional therapy at the investigator's discretion. Cohorts of 3-6 patients receive escalating doses of BMS-214662 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 4 weeks.

PROJECTED ACCRUAL: A maximum of 18-21 patients will be accrued for this study within 12-15 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor unresponsive to standard therapy or for which no effective therapy exists Measurable or evaluable disease amenable to CT-guided or percutaneous needle biopsy No active symptomatic brain metastases requiring steroids, including evidence of cerebral edema on CT scan or MRI or progression from prior imaging study

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/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL ALT/AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No history of clinically significant cardiac arrhythmia that could be exacerbated by QT interval prolongation No uncontrolled or significant cardiovascular disease No myocardial infarction within the past 6 months No significant congestive heart failure No second- or third- degree heart block No prolonged QTc interval (greater than 450 ms) on EKG Pulmonary: No uncontrolled or significant pulmonary disease Other: No serious uncontrollable medical disorder or active infection that would preclude study No dementia or altered mental status that would preclude study 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 Chemotherapy: No more than 2 prior chemotherapy regimens Prior taxanes allowed At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent antineoplastic hormonal therapy Concurrent hormone replacement therapy allowed Radiotherapy: At least 4 weeks since prior wide-field radiotherapy No concurrent radiotherapy Surgery: Not specified Other: At least 4 weeks since prior investigational drugs At least 7 days since prior substrates of cytochrome P450-3A4 (CYP3A4) No other concurrent experimental anticancer medications No concurrent dolasetron or droperidol No medications or other agents known to prolong the QT interval for at least 4 half-lives prior to, during, and for 24 hours after administration of BMS-214662 Concurrent antihistamines allowed

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006018

Locations
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106-5065
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Scot C. Remick, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Scot C. Remick, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00006018     History of Changes
Other Study ID Numbers: CWRU4Y99, U01CA062502, P30CA043703, CWRU-4Y99, NCI-290
Study First Received: July 5, 2000
Last Updated: June 10, 2010
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014