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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00026156
First received: November 9, 2001
Last updated: February 12, 2013
Last verified: February 2013
  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 vinorelbine followed by docetaxel in treating patients who have advanced non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: docetaxel
Drug: vinorelbine tartrate
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 Sequential Vinorelbine and Docetaxel in Advanced Non-Small Cell Lung Cancer Patients Age Seventy and Older, or With Performance Status 2

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Enrollment: 125
Study Start Date: November 2001
Study Completion Date: November 2008
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Detailed 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.)

  Eligibility

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

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
  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: NCT00026156

  Show 96 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Paul J. Hesketh, MD Steward St. Elizabeth's Medical Center of Boston, Inc.
  More Information

Additional Information:
Publications:
Hesketh PJ, Lilenbaum R, Chansky K, et al.: Chemotherapy in patients > 80 with advanced non small cell lung cancer: combined results from SWOG 0027 and LUN 6. [Abstract] J Clin Oncol 23 (Suppl 16): A-7147, 657s, 2005.
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): A-7056, 630s, 2004.

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00026156     History of Changes
Other Study ID Numbers: CDR0000068991, S0027, U10CA032102
Study First Received: November 9, 2001
Last Updated: February 12, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
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

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

ClinicalTrials.gov processed this record on July 22, 2014