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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
N/A
Not Enrolling
Both
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
Characteristics

Type of Study:

Interventional

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

Authority:

United States: Federal Government

Study ID:

CDR0000065871

NCT ID:

NCT00003117

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Rhode Island HospitalProvidence, Rhode Island  02903
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Massey Cancer CenterRichmond, Virginia  23298-0037
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
North Shore University HospitalManhasset, 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 CenterChicago, Illinois  60612
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140