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

NCT00683904 | Completed Phase 1 Results DMC

• 1 other identifier: CA163-160
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Dose-limiting Toxicity (DLT)

  DLT is defined as any of the following: Common Terminology Criteria (CTC), Version 3, Grade(Gr) 4 neutropenia (absolute neutrophil count \<500 cells/mm\^3) for at least 5 days or febrile neutropenia; Gr 4 thrombocytopenia (\<25,000 cells/mm\^3 or bleeding needing platelet transfusion); Gr 3 or 4 nausea, vomiting, or diarrhea, despite medical intervention; any other drug-related Gr 3 or 4 nonhematologic toxicity, except Gr 3 injection site reaction, fatigue/asthenia, transient arthralgia/myalgia, or transient electrolytes abnormal. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening.

  Days 1 through 21 (Cycle 1)

• Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2

  The MTD was defined as the highest dose evaluated for which less than one sixth of patients experience a DLT in Cycle 1. The recommended phase 2 dose is the MTD defined in Cycle 1, with consideration given to chronic cumulative toxicity occurring at later cycles.

  Days 1 through 21 (Cycle 1)

Secondary Outcomes (13)

• Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation

  Days 1 through 21 (Cycle 1)

• Number of Participants With Grade 3 or Greater Treatment-related AEs

  Days 1 through 21 (Cycle 1)

• Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade

  At screening and Days 8 and 15 of Cycle 1 (21 days)

• Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade

  At screening and Days 8 and 15 of Cycle 1 (21 days)

• Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade

  At screening and Days 8 and 15 of Cycle 1 (21 days)

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

Interventions

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

Also known as: IXEMPRA, BMS-247550

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

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

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• R-Pharm: lead

Study Sites (1)

Local Institution

Chuo-Ku, Tokyo, 104-0045, Japan

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ixabepilone; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 26, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 10, 2016
• Results First Posted: April 15, 2011

Record last verified: 2016-02

Locations

JP (1)