S0027: Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Phase II Trial of Sequential Vinorelbine and Docetaxel in Advanced Non-Small Cell Lung Cancer Patients Age Seventy and Older, or With Performance Status 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00026156
• Other study ID #: CDR0000068991
• Secondary ID: S0027U10CA032102
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2001
• Last updated: February 12, 2013
• Start date: November 2001
• Est. completion date: November 2008

Study information

• Verified date: February 2013
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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 vinorelbine followed by docetaxel in treating patients who have advanced non-small cell lung cancer.

Description:

OBJECTIVES:

• Determine the survival of patients with advanced non-small cell lung cancer who are either age 70 and over or who have performance status 2, when treated with sequential vinorelbine and docetaxel. (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003.)

• Determine the objective tumor response rates, including confirmed and unconfirmed and complete and partial, in patients treated with this regimen.

• Assess the dose delivered and the reported functional symptom status of patients treated with this regimen.

• Determine the toxic effects of this regimen in these patients.

• Determine the feasibility of performing pharmacokinetic studies and obtaining pharmacokinetic data on these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to age and performance status (age 70 and over with Zubrod 0-1 vs age 18 and over with Zubrod 2). (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003.)

Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Beginning 2 weeks after the last dose of vinorelbine, patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, at the beginning of courses 2-6, and at week 22.

Patients are followed at week 22, every 3 months for 1 year, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A minimum of 95 patients (55 patients age 70 and over with Zubrod 0-1 and 40 patients age 18 and over with Zubrod 2) will be accrued for this study within 12-18 months. (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 2008
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed, newly diagnosed, advanced primary non-small cell lung cancer (NSCLC) (adenocarcinoma, large cell carcinoma, squamous cell carcinoma, or unspecified), designated as 1 of the following stages:

• Selected stage IIIB (excluding Pancoast tumors)

• T4 lesion due to malignant pleural effusion OR

• Multiple lesions in a single lobe containing a T3 or T4 primary

• Stage IV (any T, any N, M1)

• Recurrent disease after prior surgery and/or radiotherapy

• Measurable or evaluable disease outside of prior radiation port

• No bronchoalveolar carcinoma

• No brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-1 (for age 70 and over) (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003)

• Zubrod 2 (for age 18 and over)

Life expectancy:

• Not specified

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than upper limit of normal (ULN)

• SGOT/SGPT no greater than 2 times ULN if alkaline phosphatase is no greater than ULN OR

• Alkaline phosphatase no greater than 4 times ULN if SGOT/SGPT are no greater than ULN

Renal:

• Not specified

Other:

• No prior severe hypersensitivity to docetaxel or other drugs formulated with polysorbate 80

• No grade 2 or greater sensory neuropathy

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior or concurrent biologic therapy for NSCLC

• No concurrent filgrastim (G-CSF)

Chemotherapy:

• No prior systemic chemotherapy for NSCLC

Endocrine therapy:

• No prior or concurrent hormonal therapy for NSCLC

Radiotherapy:

• See Disease Characteristics

• At least 3 weeks since prior radiotherapy and recovered

• Concurrent palliative radiotherapy to small-field nonmeasurable lesions (i.e., painful bony lesions) allowed

• No other concurrent radiotherapy

Surgery:

• See Disease Characteristics

• At least 3 weeks since prior thoracic or other major surgery and recovered

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• docetaxel

• vinorelbine tartrate

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center - Albany	Albany	New York
United States	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico
United States	Veterans Affairs Medical Center - Albuquerque	Albuquerque	New Mexico
United States	CCOP - Ann Arbor Regional	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Veterans Affairs Medical Center - Ann Arbor	Ann Arbor	Michigan
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Veterans Affairs Medical Center - Biloxi	Biloxi	Mississippi
United States	Boston Medical Center	Boston	Massachusetts
United States	St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Veterans Affairs Medical Center - Charleston	Charleston	South Carolina
United States	MBCCOP - University of Illinois at Chicago	Chicago	Illinois
United States	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois
United States	Barrett Cancer Center	Cincinnati	Ohio
United States	Veterans Affairs Medical Center - Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Genesis Medical Center	Davenport	Iowa
United States	CCOP - Dayton	Dayton	Ohio
United States	Veterans Affairs Medical Center - Dayton	Dayton	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Veterans Affairs Medical Center - Denver	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	Veterans Affairs Medical Center - Detroit	Detroit	Michigan
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Dwight David Eisenhower Army Medical Center	Fort Gordon	Georgia
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	University of Texas Medical Branch	Galveston	Texas
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	CCOP - Greenville	Greenville	South Carolina
United States	Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)	Hines	Illinois
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	Tripler Army Medical Center	Honolulu	Hawaii
United States	Veterans Affairs Medical Center - Houston	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Veterans Affairs Medical Center - Jackson	Jackson	Mississippi
United States	Veterans Affairs Medical Center - Boston (Jamaica Plain)	Jamaica Plain	Massachusetts
United States	CCOP - Kansas City	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri
United States	Keesler Medical Center - Keesler AFB	Keesler AFB	Mississippi
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	Veterans Affairs Medical Center - Lexington	Lexington	Kentucky
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Veterans Affairs Medical Center - Little Rock (McClellan)	Little Rock	Arkansas
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Veterans Affairs Medical Center - West Los Angeles	Los Angeles	California
United States	Veterans Affairs Outpatient Clinic - Martinez	Martinez	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Tennessee Cancer Institute	Memphis	Tennessee
United States	MBCCOP - Gulf Coast	Mobile	Alabama
United States	MBCCOP - LSU Medical Center	New Orleans	Louisiana
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Herbert Irving Comprehensive Cancer Center	New York	New York
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Veterans Affairs Medical Center - Oklahoma City	Oklahoma City	Oklahoma
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	CCOP - Greater Phoenix	Phoenix	Arizona
United States	Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)	Phoenix	Arizona
United States	CCOP - Columbia River Program	Portland	Oregon
United States	Oregon Cancer Institute	Portland	Oregon
United States	Veterans Affairs Medical Center - Portland	Portland	Oregon
United States	University of Rochester Medical Center	Rochester	New York
United States	CCOP - Beaumont	Royal Oak	Michigan
United States	University of California Davis Cancer Center	Sacramento	California
United States	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri
United States	St. Louis University Health Sciences Center	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Veterans Affairs Medical Center - Salt Lake City	Salt Lake City	Utah
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas
United States	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	Veterans Affairs Medical Center - Seattle	Seattle	Washington
United States	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana
United States	Veterans Affairs Medical Center - Shreveport	Shreveport	Louisiana
United States	Providence Hospital - Southfield	Southfield	Michigan
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	CCOP - Northwest	Tacoma	Washington
United States	Madigan Army Medical Center	Tacoma	Washington
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	Veterans Affairs Medical Center - Temple	Temple	Texas
United States	David Grant Medical Center	Travis Air Force Base	California
United States	Arizona Cancer Center	Tucson	Arizona
United States	Veterans Affairs Medical Center - Tucson	Tucson	Arizona
United States	MBCCOP - Howard University Cancer Center	Washington	District of Columbia
United States	CCOP - Wichita	Wichita	Kansas
United States	Veterans Affairs Medical Center - Wichita	Wichita	Kansas
United States	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hesketh PJ, Chansky K, Lau DH, Doroshow JH, Moinpour CM, Chapman RA, Goodwin JW, Gross HM, Crowley JJ, Gandara DR. Sequential vinorelbine and docetaxel in advanced non-small cell lung cancer patients age 70 and older and/or with a performance status of 2: — View Citation

Hesketh PJ, Chansky K, Lau DH, et al.: Sequential vinorelbine (V) and docetaxel (D) in advanced non-small cell lung cancer (NSCLC) patients age > 70, or with performance status (PS) 2: a SWOG phase II trial (S0027). [Abstract] J Clin Oncol 22 (Suppl 14):

Hesketh PJ, Lilenbaum RC, Chansky K, Dowlati A, Graham P, Chapman RA, Crowley JJ, Gandara DR. Chemotherapy in patients > or = 80 with advanced non-small cell lung cancer: combined results from SWOG 0027 and LUN 6. J Thorac Oncol. 2007 Jun;2(6):494-8. — View Citation