Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00026156

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 ditartrate	Phase II

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Vinorelbine Docetaxel Vinorelbine tartrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

November 2001

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026156

Show 96 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Paul J. Hesketh, MD

Caritas St. Elizabeth's Medical Center of Boston

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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: a phase II trial of the Southwest Oncology Group (S0027). J Thorac Oncol. 2006 Jul;1(6):537-44.

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.

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.

Study ID Numbers:	CDR0000068991, SWOG-S0027
Study First Received:	November 9, 2001
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00026156 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Thoracic Neoplasms
Vinblastine
Antimitotic Agents
Recurrence
Carcinoma
Docetaxel
Vinorelbine
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Adenocarcinoma of Lung
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Vinblastine
Antimitotic Agents
Pharmacologic Actions
Carcinoma
Docetaxel

Neoplasms
Neoplasms by Site
Vinorelbine
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009