Liposomal SN-38 in Treating Patients With Small Cell Lung Cancer

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 phase II trial is studying how well liposomal SN-38 works in treating patients with small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Irinotecan

Criteria

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