S0027: Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
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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 |
| 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) |
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 |
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
Show 96 Study Locations| Study Chair: | Paul J. Hesketh, MD | Steward St. Elizabeth's Medical Center of Boston, Inc. |
More Information
Additional Information:
Publications:
| 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 May 19, 2013