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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003117
First received: November 1, 1999
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with or without carboplatin in treating patients who have recurrent, stage IIIB, or stage IV non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: paclitaxel
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Single-Agent Versus Combination Chemotherapy in Advanced NSCLC: A CALGB Randomized Trial of Efficacy, Quality of Life, and Cost-Effectiveness

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Enrollment: 584
Study Start Date: October 1997
Study Completion Date: January 2006
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel Drug: paclitaxel
Experimental: Paclitaxel + Carboplatin Drug: carboplatin Drug: paclitaxel

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003117

  Show 35 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Rogerio C. Lilenbaum, MD Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003117     History of Changes
Other Study ID Numbers: CDR0000065871, U10CA031946, CLB-9730
Study First Received: November 1, 1999
Last Updated: September 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014