Clinical trial NCT00683904: Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer
Official title: A Phase I Study of Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer as First-line Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer (NSCLC)
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2008-05-26
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Dose-limiting Toxicity (DLT)
timeFrame: Days 1 through 21 (Cycle 1)
measure: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2
timeFrame: Days 1 through 21 (Cycle 1)
Secondary outcomes:
measure: Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation
timeFrame: Days 1 through 21 (Cycle 1)
measure: Number of Participants With Grade 3 or Greater Treatment-related AEs
timeFrame: Days 1 through 21 (Cycle 1)
measure: Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
timeFrame: At screening and Days 8 and 15 of Cycle 1 (21 days)
measure: Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade
timeFrame: At screening and Days 8 and 15 of Cycle 1 (21 days)
measure: Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade
timeFrame: At screening and Days 8 and 15 of Cycle 1 (21 days)
measure: Number of Participants With Abnormalities in Blood Pressure and Heart Rate
timeFrame: At screening and Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)
measure: Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: At screening of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)
measure: Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment
timeFrame: Days 1 through 21 (Cycle 1)
measure: Maximum Observed Plasma Concentration of Ixabepilone
timeFrame: Days 1 to 8 of Cycle 1 (21 days)
measure: Time of Maximum Observed Plasma Concentration of Ixabepilone
timeFrame: Days 1 to 8 of Cycle 1 (21 days)
measure: Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone
timeFrame: Days 1 to 8 of Cycle 1 (21 days)
measure: Volume of Distribution at Steady State of Ixabepilone
timeFrame: Days 1 to 8 of Cycle 1 (21 days)
measure: Total Body Clearance of Ixabepilone
timeFrame: Days 1 to 8 of Cycle 1 (21 days)
Other outcomes:
Locations:
city: Chuo-Ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: