Overview
Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy
Status:
Completed
Completed
Trial end date:
2004-12-01
2004-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Drugs used in chemotherapy, such as epothilone D, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well epothilone D works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to platinum-based chemotherapy.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Memorial Sloan Kettering Cancer CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Desoxyepothilone B
Epothilones
Criteria
DISEASE CHARACTERISTICS:- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIB* or IV disease NOTE: *Due to malignant pleural effusion or
supraclavicular lymph node involvement only
- Previously treated with maximally feasible surgical resection and/or radiotherapy for
initial disease
- Failed 1 prior platinum-containing chemotherapy regimen for advanced or metastatic
disease due to disease progression or treatment toxicity
- At least 1 site of unidimensionally measurable disease by physical exam or radiography
- No known CNS metastases or leptomeningeal metastases requiring corticosteroids
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- More than 3 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Hemoglobin ≥ 8 g/dL
- Platelet count ≥ 75,000/mm^3
Hepatic
- AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with hepatic
metastases)
- Alkaline phosphatase ≤ 5 times ULN
- Bilirubin ≤ 1.8 mg/dL
Renal
- Creatinine ≤ 2.0 mg/dL
Cardiovascular
- No New York Heart Association class III or IV congestive heart failure
- No personal or family history of congenital long QT syndrome
- No QTc interval > 450 msec (males) or > 470 msec (females) by ECG
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No preexisting neuropathy ≥ grade 2
- No other malignancy within the past 5 years except for the following:
- Cured basal cell skin cancer
- Carcinoma in situ of the cervix or urinary bladder
- Stage T1 or T2 prostate cancer with prostate-specific antigen < 2 ng/mL
- No hypersensitivity reaction ≥ grade 3 to prior Cremophor-containing therapy
- No infection requiring parenteral or oral anti-infective therapy
- No weight loss of ≥ 10% within the past 3 months
- No altered mental status or psychiatric illness that would preclude giving informed
consent
- No other medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent granulocyte-macrophage colony-stimulating factor (sargramostim [GM-CSF])
- No concurrent routine prophylactic granulocyte colony-stimulating factor (filgrastim
[G-CSF])
Chemotherapy
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy and recovered
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
Surgery
- See Disease Characteristics
- At least 3 weeks since prior surgery and recovered
Other
- Prior adjuvant or neoadjuvant therapy allowed
- Prior radiosensitizers allowed
- At least 2 weeks since prior gefitinib
- More than 3 weeks since prior investigational agents (therapeutic or diagnostic)
- No other concurrent investigational agents
- No other concurrent anticancer treatment