Phase 1
N=6
Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer
Non-small Cell Lung Cancer (NSCLC)
Bottom Line
View on ClinicalTrials.gov: NCT00683904 ↗Enrolled (actual)
6
Serious AEs
8.3%
Results posted
Apr 2011
Primary outcome: Primary: Number of Participants With Dose-limiting Toxicity (DLT) — 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL (Drug); Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- R-Pharm
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-limiting Toxicity (DLT) |
0; 1 | — |
| PRIMARY Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2 |
6 | — |
| SECONDARY Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Grade 3 or Greater Treatment-related AEs |
5; 4; 4; 4; 4; 1 | — |
| SECONDARY Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade |
0; 0; 2; 5; 4; 1 | — |
| SECONDARY Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade |
3; 2; 2; 1; 0; 1 | — |
| SECONDARY Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade |
2; 2; 3; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormalities in Blood Pressure and Heart Rate |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment |
0; 0; 2; 1; 2; 0 | — |
| SECONDARY Maximum Observed Plasma Concentration of Ixabepilone |
195.77; 250.32 | — |
| SECONDARY Time of Maximum Observed Plasma Concentration of Ixabepilone |
2.61; 2.43 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone |
1542.11; 2135.93 | — |
| SECONDARY Volume of Distribution at Steady State of Ixabepilone |
1131.02; 1122.82 | — |
| SECONDARY Total Body Clearance of Ixabepilone |
33.64; 25.20 | — |
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
Data sourced from ClinicalTrials.gov (NCT00683904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.