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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group Identifier:
First received: November 1, 1999
Last updated: July 20, 2012
Last verified: July 2012

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00002969

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

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 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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on October 26, 2016