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

November 9, 2001
February 12, 2013
November 2001
July 2004   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00026156 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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S0027: Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
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

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.

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.)

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: docetaxel
  • Drug: vinorelbine tartrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
November 2008
July 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00026156
CDR0000068991, S0027, U10CA032102
No
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Paul J. Hesketh, MD Steward St. Elizabeth's Medical Center of Boston, Inc.
Southwest Oncology Group
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP