Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	SWOG-S0327 S0327, NCT00068289

Objectives

1. Determine the efficacy of bortezomib, in terms of response rate (confirmed and unconfirmed, complete and partial), in patients with recurrent or refractory extensive stage small cell lung cancer previously treated with platinum-based therapy.
2. Determine the qualitative and quantitative toxic effects of this drug in these patients.
3. Determine the overall survival of patients treated with this drug.
4. Correlate selected molecular markers with outcomes in patients treated with this drug.

Entry 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)

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 40-80 patients (20-40 per stratum) will be accrued for this study within 0.5-1 year.

Outline

Patients are stratified according to platinum-sensitivity status (platinum sensitive [temporarily closed to accrual as of 8/1/04] vs platinum refractory [temporarily closed to accrual as of 6/1/04]).

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 2 years.

Lara PN Jr, Chansky K, Davies AM, et al.: Bortezomib (PS-341) in relapsed or refractory extensive stage small cell lung cancer: a Southwest Oncology Group phase II trial (S0327). J Thorac Oncol 1 (9): 996-1001, 2006.[PUBMED Abstract]

Johl J, Chansky K, Lara PN, et al.: The proteasome inhibitor PS-341 (bortezomib) in platinum (plat)-treated extensive-stage small cell lung cancer (E-SCLC): a SWOG (0327) phase II trial. [Abstract] J Clin Oncol 23 (Suppl 16): A-7047, 632s, 2005.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Primo Lara, MD, Study coordinator		Ph: 916-734-3771
Angela Davies, MD, Study coordinator		Ph: 916-734-3771

Registry Information
Official Title		A Phase II Trial of PS-341 (NSC-681239) in Patients with Platinum-Treated Extensive Stage Small Cell Lung Cancer
Trial Start Date		2003-09-01
Registered in ClinicalTrials.gov		NCT00068289
Date Submitted to PDQ		2003-07-10
Information Last Verified		2004-08-16
NCI Grant/Contract Number		CA32102

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