Clinical trial · Interventional
Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer
A Phase I Study of Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer as First-line Treatment
NCT00683904CI-TRIAL-00021298completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL | Drug | — | UNRESOLVED |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL
- interventionNames
- Drug: Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL
- type
- ACTIVE_COMPARATOR
- label
- Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL
- interventionNames
- Drug: Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL
Primary outcomes (2)
- measure
- Number of Participants With Dose-limiting Toxicity (DLT)
- timeFrame
- Days 1 through 21 (Cycle 1)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.