NCT00068289
Bortezomib in Treating Patients With Recurrent or Refractory Extensive-Stage Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
PHASE2
COMPLETED
NCT00068289
INTERVENTIONAL
A Phase II Trial of PS-341 (NSC-681239) in Patients With Platinum-Treated Extensive Stage Small Cell Lung Cancer
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).
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
Lung Cancer
- TREATMENT
-
- Type: DRUG
- Name: bortezomib
- Description:
- Arm Group Labels:
- SWOG Cancer Research Network