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Single-Agent Versus Combination Chemotherapy in Advanced NSCLC: A CALGB Randomized Trial of Efficacy, Quality of Life, and Cost-Effectiveness

Phase 3
18 Years
Not Enrolling
Lung Cancer

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Trial Information

Single-Agent Versus Combination Chemotherapy in Advanced NSCLC: A CALGB Randomized Trial of Efficacy, Quality of Life, and Cost-Effectiveness

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.

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.

PROJECTED ACCRUAL: This study will accrue 600 patients over 2 years.

Inclusion 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

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Rogerio C. Lilenbaum, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center


United States: Federal Government

Study ID:




Start Date:

October 1997

Completion Date:

January 2006

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Medical University of South Carolina Charleston, South Carolina  29425-0721
Rhode Island Hospital Providence, Rhode Island  02903
Vermont Cancer Center Burlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
Massey Cancer Center Richmond, Virginia  23298-0037
Dana-Farber Cancer Institute Boston, Massachusetts  02115
North Shore University Hospital Manhasset, New York  11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
University of Illinois at Chicago Health Sciences Center Chicago, Illinois  60612
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Mount Sinai Comprehensive Cancer Center Miami Beach, Florida  33140