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

NCT00006018 | Completed Phase 1 DMC

• 5 other identifiers: CWRU4Y99U01CA062502P30CA043703CWRU-4Y99NCI-290
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose of BMS-214662 in combination with paclitaxel.

  Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Interventions

BMS-214662 DRUG

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.

paclitaxel DRUG

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.

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Ireland Cancer Center at University Hospitals Case Medical Center

Cleveland, Ohio, 44106-5065, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

MeSH Terms

Interventions

7-cyano-2,3,4,5-tetrahydro-1-(1H-imidazol-4-ylmethyl)-3-(phenylmethyl)-4-(2-thienylsulfonyl)-1H-1,4-benzodiazepine; Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Scot C. Remick, MD

  Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: March 8, 2004
• Study Start: July 1, 2000
• Primary Completion: December 1, 2001
• Study Completion: April 1, 2002
• Last Updated: June 11, 2010

Record last verified: 2010-06

Locations

US (2)