Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer

NCT ID: NCT00683904

Last Updated: 2016-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-09-30

Brief Summary

The purpose of this study is to determine the maximum tolerated dose, dose-limiting toxicity, and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with non-small cell lung cancer.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL

Group Type: ACTIVE_COMPARATOR

Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL

Intervention Type: DRUG

On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m\^2, intravenous (IV) solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 5 mg/min/mL, intravenous IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.

Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL

Group Type: ACTIVE_COMPARATOR

Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL

Intervention Type: DRUG

After all participants in Dose Level 1 (ixabepilone, 32 mg/m\^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2(ixabepilone, 32 mg/m\^2 + carboplatin, 6 mg/min/mL) opened. On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m\^2, IV solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 6 mg/min/mL, IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.

Interventions

Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL

On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m\^2, intravenous (IV) solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 5 mg/min/mL, intravenous IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.

Intervention Type: DRUG

Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL

After all participants in Dose Level 1 (ixabepilone, 32 mg/m\^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2(ixabepilone, 32 mg/m\^2 + carboplatin, 6 mg/min/mL) opened. On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m\^2, IV solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 6 mg/min/mL, IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.

Intervention Type: DRUG

Other Intervention Names

IXEMPRA; BMS-247550

Eligibility Criteria

Inclusion Criteria

• Age ≥20 years
• Histologic or cytologic diagnosis of advanced non-small cell lung cancer (NSCLC)
• Advanced NSCLC, defined as stage IIIB (without indications for radiotherapy), stage IV, or recurrent
• No prior chemotherapy-containing regimens for the treatment of NSCLC
• Eastern Cooperative Oncology Group performance status of 0-1
• Life expectancy of at least 12 weeks
• Accessible for treatment and follow up; patients who could be hospitalized for first 15 days of Cycle 1
• Adequate recovery from previous systemic therapy (at least 3 weeks for surgery or radiation therapy)

Exclusion Criteria

• Women of childbearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy for study period and for up to 4 weeks after last dose of study drug
• Women pregnant or breast feeding
• Women with a positive pregnancy test result on enrollment or prior to study drug administration
• Sexually active fertile men not using effective birth control for the entire study period and for up to 3 months after the last dose of study drug if their partners are WOCBP
• Patients with symptomatic or requiring treatment for brain metastases and/or leptomeningeal metastases
• Prior radiation must not have included ≥30% of major bone-marrow-containing areas (pelvis, lumbar spine)
• Common Terminology Criteria (CTC) Grade 2 or greater neuropathy
• Psychiatric or other disorders rendering the patient incapable of complying with protocol requirements
• Any concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix (Patients with a history of malignancy but without evidence of disease for 5 years are eligible)
• Serious uncontrolled medical disorder or active systemic infection that would impair the ability of the subject to receive protocol therapy.
• Myocardial infarction, unstable angina, or unstable congestive heart failure within 6 months
• Known history of infection with human immunodeficiency virus
• Inadequate bone marrow function
• Inadequate hepatic function
• Inadequate renal function
• Known prior severe hypersensitivity reaction (CTC Grade 2 or greater) to agents containing Cremophor®EL
• Known severe hypersensitivity reaction to agents containing carboplatin and other platinum
• Prior treatment with an epothilone and/or with platinum
• History of high-dose chemotherapy with bone marrow transplant or peripheral blood stem cell support within 2 years
• On treatment with strong Cytochrome P450 3A4 inhibitor
• Current imprisonment
• Compulsorily detention for treatment of psychiatric or physical illness

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

R-Pharm

INDUSTRY

Sponsor Role: lead

Responsible Party

Bristol-Myers Squibb

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution

Chuo-Ku, Tokyo, Japan

Countries

Japan

Related Links

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

CA163-160

Identifier Type: -

Identifier Source: org_study_id