NCT00068289

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

Official Title:

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

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).

Eligibility

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

Disease(s) and\or Condition(s)

Lung Cancer

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: bortezomib
    • Description:
    • Arm Group Labels:
Sponsor
  • SWOG Cancer Research Network