Bortezomib in Treating Patients With Recurrent or Refractory Extensive-Stage Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have recurrent or refractory extensive-stage small cell lung cancer that was previously treated with platinum-based chemotherapy (such as cisplatin, carboplatin, or oxaliplatin).

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

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bortezomib

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