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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel; Vinblastine; Vinorelbine

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