Know Cancer

forgot password

A Phase I Study of Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer as First-line Treatment

Phase 1
20 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

A Phase I Study of Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer as First-line Treatment

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

- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Dose-limiting Toxicity (DLT)

Outcome 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.

Outcome Time Frame:

Days 1 through 21 (Cycle 1)

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

June 2008

Completion Date:

September 2009

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms