Duarte, California 91010

  • Lung Cancer

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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000065476


NCT ID:

NCT00002969


Secondary ID:

S9714


Study Acronym:


Brief Title:

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


Official Title:

Phase II Trial of Paclitaxel by 96-Hour Infusion in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Southwest Oncology Group


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Actual


Overall Contact Information

Official Name:Ralph B. Vance, MD
Study Chair
University of Mississippi Cancer Clinic

Study Dates

Start Date:May 1997
Completion Date:January 2007
Completion Type:Actual
Primary Completion Date:January 2004
Primary Completion Type:Actual
Verification Date:July 2012
Last Changed Date:July 20, 2012
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:paclitaxel

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Southwest Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Gandara DR, West H, Chansky K, Davies AM, Lau DH, Crowley J, Gumerlock PH, Hirsch FR, Franklin WA. Bronchioloalveolar carcinoma: a model for investigating the biology of epidermal growth factor receptor inhibition. Clin Cancer Res. 2004 Jun 15;10(12 Pt 2):4205s-4209s. Review.
PMID:15217959
Reference Type:Results Reference
Citation:West HL, Crowley JJ, Vance RB, Franklin WA, Livingston RB, Dakhil SR, Giguere JK, Rivkin SE, Kraut M, Chansky K, Gandara DR; Southwest Oncology Group. Advanced bronchioloalveolar carcinoma: a phase II trial of paclitaxel by 96-hour infusion (SWOG 9714): a Southwest Oncology Group study. Ann Oncol. 2005 Jul;16(7):1076-80. Epub 2005 Apr 28.
PMID:15860488
Reference Type:Results Reference
Citation: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.
Reference Type:Results Reference
Citation: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.

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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