A Phase II Trial of PS-341 (NSC-681239) in Patients With Platinum-Treated Extensive Stage Small Cell Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed extensive stage small cell lung cancer

- Diagnosis by sputum cytology allowed provided it is confirmed by an independent
pathologic review

- Clinical evidence of recurrent or refractory disease does not require a
confirmatory biopsy

- Measurable disease by plain radiographs, CT scan, or MRI

- Prior radiotherapy to measurable disease allowed provided there is evidence of
disease progression by CT scan OR there is measurable disease outside of the
radiotherapy field

- Must have received a prior platinum-based chemotherapy regimen and meet criteria for
1 of the following:

- Platinum-sensitive disease, defined as an initial response with subsequent
progression more than 90 days after last platinum treatment (temporarily closed
to accrual as of 8/1/04)

- Platinum-refractory disease, defined as no response to or progression during
platinum treatment or subsequent progression no more than 90 days after last
platinum treatment (temporarily closed to accrual as of 6/1/04)

- Brain and/or leptomeningeal metastases are allowed provided all of the following are
true:

- Asymptomatic on neurological exam

- No concurrent corticosteroids for symptom control

- No concurrent enzyme-inducing anticonvulsants (e.g., phenytoin or phenobarbital)

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Not specified

Renal

- Creatinine no greater than upper limit of normal OR

- Creatinine clearance at least 60 mL/min

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No symptomatic sensory neuropathy greater than grade 1

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or any other adequately
treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- At least 3 weeks since prior chemotherapy

Endocrine therapy

- See Disease Characteristics

Radiotherapy

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy

- No concurrent radiotherapy to measurable lesions

Surgery

- At least 14 days since prior thoracic or other major surgery and recovered

- Must have disease outside of the prior surgical resection area OR new lesion
must be present