S9714: Paclitaxel in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00002969
First received: November 1, 1999
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy with paclitaxel in treating patients with stage IIIB or stage IV non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Paclitaxel by 96-Hour Infusion in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Enrollment: 60
Study Start Date: May 1997
Study Completion Date: January 2007
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Assess survival, progression-free survival and response rate of patients with bronchioloalveolar carcinoma receiving paclitaxel. II. Evaluate toxic effects of paclitaxel in 96 hour continuous infusion patients.

OUTLINE: Patients receive 6 cycles of paclitaxel by IV continuous infusion over 96 hours. Before cycle 4, restaging is performed. If disease progression is witnessed, patients are removed from the study. If a stable, partial, or complete response is observed, patients receive the total of 6 cycles. Three weeks after the last cycle, final restaging is performed. Patients are followed every 3 months while on treatment and every 6 months thereafter, unless more frequent follow-up is clinically recommended.

PROJECTED ACCRUAL: 50 patients will be enrolled. The accrual rate is estimated at 25 per year.

  Eligibility

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

DISEASE CHARACTERISTICS: Histologically proven Stage IIIB or IV bronchioloalveolar non-small cell lung carcinoma -incompletely resected or unresectable -tumors may be multifocal or diffuse -measurable or evaluable disease required No prior brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: SWOG 0-2 Life Expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than institutional upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than institutional ULN OR creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Effective contraceptive method used while on study No prior malignancies allowed, except: basal or squamous cell skin cancer in situ cervical cancer Stage I or II cancer which is in remission Any cancer from which patients have been disease free for 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for lung cancer Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy (including palliative radiotherapy) Surgery: Prior surgery is allowed

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002969

  Show 85 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Ralph B. Vance, MD University of Mississippi Cancer Clinic
  More Information

Additional Information:
Publications:
Franklin WA, Gumerlock PH, Crowley J, et al.: EGFR, HER2 and ERB-B pathway activation in bronchioloalveolar carcinoma (BAC): analysis of SWOG 9417 and lung SPORE tissue samples. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2493, 2003.
Vance RB, Crowly JJ, Livingston RB, et al.: A phase II Southwest Oncology Group trial (S9714) utilizing paclitaxel by 96-hour infusion in stage IIIb and IV bronchioloalveolar carcinoma of the lung (BAC). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1340, 336a, 2001.

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00002969     History of Changes
Other Study ID Numbers: CDR0000065476, S9714, U10CA032102
Study First Received: November 1, 1999
Last Updated: July 20, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

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

ClinicalTrials.gov processed this record on April 16, 2014