Status:
WITHDRAWN
Liposomal SN-38 in Treating Patients With Small Cell Lung Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
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 liposomal SN-38, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This ...
Detailed Description
OBJECTIVES: * Determine the response rate in patients with small cell lung cancer treated with SN-38 liposome that is dosed according to a UGT1A1-specific genotype. * Determine the toxicity of this d...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer meeting 1 of the following criteria:
- Previously untreated disease
- Extensive stage disease, as defined by any of the following:
- Metastatic disease outside of the chest
- Contralateral supraclavicular or contralateral hilar nodes that cannot be included in a single radiation port
- Malignant pleural effusion
- Previously treated disease
- Limited or extensive stage disease
- Measurable disease
- Lesions ≥ 1 cm and \< 2 cm must be measured by spiral CT scan for pre- and post-treatment tumor assessment
- UGT1A1\*28 genotype wt/wt (6/6 promoter TA repeats) OR wt/\*28 (6/7 promoter TA repeats)
- No \*28/\*28 (7/7 promoter TA repeats) genotype
- No mixed histology
- No uncontrolled CNS metastasis
- Previously treated, stable CNS metastasis allowed
- No superior vena cava syndrome
- No malignant pericardial effusion
- No near obstruction of the trachea or main stem bronchi
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Total bilirubin \< 1.5 times upper limit of normal (ULN) OR
- Direct bilirubin normal
- Renal
- Creatinine \< 1.5 times ULN
- Cardiovascular
- No unstable angina pectoris
- No uncontrolled congestive heart failure
- No myocardial infarction within the past 3 months
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study participation
- No syndrome of inappropriate antidiuretic hormone secretion
- No ectopic adrenocorticotrophic syndrome
- No Lambert-Eaton myasthenic syndrome
- No other severe paraneoplastic syndrome
- No active infection requiring oral or parenteral antibiotics
- No other life threatening disease
- No other malignancy except basal cell or squamous cell skin cancer, localized prostate cancer, superficial bladder cancer, or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent filgrastim (G-CSF) during course 1 of study treatment
- Chemotherapy
- No more than 1 prior chemotherapy regimen for this malignancy
- Prior cyclophosphamide, doxorubicin, and vincristine (CAV) alternating with etoposide and cisplatin (EP) allowed
- More than 21 days since prior chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- More than 14 days since prior radiotherapy
- Concurrent palliative radiotherapy allowed except radiotherapy to a solitary measured index lesion
- Surgery
- More than 21 days since prior major surgery
- Other
- No other concurrent treatment for this malignancy
- No other concurrent investigational treatment
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00104754
Last Update
July 20 2016
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