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

Alternate Title

Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	CLB-9730 NCT00003117, CALGB-9730

Objectives

I.   Compare the overall survival of patients with non-small cell lung cancer 
treated with paclitaxel alone or in combination with carboplatin.

II.  Compare the quality of life of these patients treated with these 
chemotherapy regimens.

III.  Compare the response rates and the toxic effects of the two regimens in 
this patient population.

Entry Criteria

Disease Characteristics:

Histologically or cytologically proven non-small cell lung cancer
(adenocarcinoma, large cell, squamous cell, or mixture)

Stage IIIB due to any of the following:
 Malignant pleural effusion
 Supraclavicular node involvement
 Contralateral hilar node involvement
 Not eligible for CALGB protocols of combined therapy and chest irradiation

Stage IV

Any stage that has recurred or progressed after surgery or radiotherapy

Measurable or evaluable disease
 Does not include the following:
  Bone metastases
  Pleural or peritoneal effusions
  Irradiated lesions, unless progression documented after radiation therapy

No CNS metastases

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified   

Chemotherapy:
 No prior chemotherapy
 No other concurrent chemotherapy

Endocrine therapy:
 No concurrent hormones except steroids for adrenal failure, hormones for     
  nondisease related conditions (e.g., insulin for diabetes), or dexamethasone

Radiotherapy:
 At least 2 weeks since prior radiotherapy
 See Disease Characteristics

Surgery:
 Prior surgery allowed
 See Disease Characteristics

Patient Characteristics:

Age:
 18 and over

Performance status:
 CALGB 0-2

Life expectancy:
 Not specified

Hematopoietic:
 Granulocyte count at least 1500/mm3
 Platelet count at least 100,000/mm3

Hepatic:
 Bilirubin less than 1.5 mg/dL
 SGOT less than 2 times the upper limit of normal (ULN)

Renal:
 Creatinine no greater than 2 times ULN

Other:
 No prior or concurrent malignancy except:
  Curatively treated carcinoma in situ of the cervix
  Curatively treated breast cancer
  Curatively treated basal cell or squamous cell skin cancer
  At least 5 years since any nonrecurrent primary tumor surgically resected   
   without administration of adjuvant radiation therapy or chemotherapy
 HIV negative

Expected Enrollment

This study will accrue 600 patients over 2 years.

Outline

This is a randomized study.  Patients are stratified according to stage of 
disease (stage IIIB vs stage IV vs recurrent or progressive after surgery 
and/or radiotherapy), performance status (0-1 vs 2), and age (under 70 vs 70 
and over).

Patients are randomized to one of two treatment arms.  Arm I receives 
paclitaxel IV over 3 hours on day 1 of each course.  Arm II receives 
paclitaxel as in Arm I, followed by carboplatin IV over 1 hour.  Treatment is 
repeated every 21 days for 6 courses in the absence of tumor progression or 
unacceptable toxicity.

Quality of life assessments are conducted before treatment and at 2, 6, 9, and 
12 months.

Patients are followed every 3 months for 2 years, then every 6 months until 
disease progression or death.

Lilenbaum RC, Herndon JE 2nd, List MA, et al.: Single-agent versus combination chemotherapy in advanced non-small-cell lung cancer: the cancer and leukemia group B (study 9730). J Clin Oncol 23 (1): 190-6, 2005.[PUBMED Abstract]

Lilenbaum RC, Herndon J, List M, et al.: Single-agent (SA) versus combination chemotherapy (CC) in advanced non-small cell lung cancer (NSCLC): a CALGB randomized trial of efficacy, quality of life (QOL), and cost-effectiveness. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2, 2002.

Lamont EB, Herndon JE 2nd, Weeks JC, et al.: Measuring clinically significant chemotherapy-related toxicities using Medicare claims from Cancer and Leukemia Group B (CALGB) trial participants. Med Care 46 (3): 303-8, 2008.[PUBMED Abstract]

Lamont EB, Herndon JE 2nd, Weeks JC, et al.: Criterion validity of Medicare chemotherapy claims in Cancer and Leukemia Group B breast and lung cancer trial participants. J Natl Cancer Inst 97 (14): 1080-3, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Rogerio Lilenbaum, MD, Protocol chair		Ph: 305-535-3310 Email: rlilenbaum@aptiumoncology.com

Registry Information
Official Title		Single-Agent Versus Combination Chemotherapy in Advanced NSCLC: A CALGB Randomized Trial of Efficacy, Quality of Life, and Cost-Effectiveness
Trial Start Date		1997-10-15
Registered in ClinicalTrials.gov		NCT00003117
Date Submitted to PDQ		1997-10-15
Information Last Verified		2009-08-18
NCI Grant/Contract Number		U10-CA31946

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