Status:
COMPLETED
Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ep...
Detailed Description
OBJECTIVES: Primary * Determine the antitumor activity of epothilone D, in terms of confirmed objective response rate, in patients with stage IIIB or IV non-small cell lung cancer who failed prior i...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00081107
Start Date
December 1 2003
End Date
December 1 2004
Last Update
June 5 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021