S9806: Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

SWOG Cancer Research Network

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Drug: gemcitabine; Drug: carboplatin; Drug: paclitaxel; Drug: docetaxel; Drug: cisplatin; Drug: vinorelbine

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00003587

S9806 (Other Identifier)

CDR0000066656

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of two different combination chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer

Full description

OBJECTIVES: I. Assess the survival and failure free survival of patients with advanced primary non-small cell lung cancer treated with carboplatin and gemcitabine followed by paclitaxel OR cisplatin and vinorelbine followed by docetaxel. II. Evaluate the response (confirmed plus unconfirmed) and toxicities associated with these two regimens in these patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive carboplatin IV over 30 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses. Following the 3 courses of carboplatin and gemcitabine, patients receive paclitaxel IV over 3 hours on day 1 every 21 days for 3 courses. Arm II: Patients receive cisplatin IV over 30-60 minutes on day 1 followed by vinorelbine IV over 6-10 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses. Following the 3 courses of cisplatin and vinorelbine, patients receive docetaxel IV over 1 hour on day 1 every 21 days for 3 courses. Patients receive no further treatment until evidence of disease progression. Patients are followed every 2 months for the first year, every 6 months for years 2 and 3, and annually thereafter.

PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed stage IIIB or IV advanced primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous cell carcinoma, or unspecified) or recurrent non-small cell lung cancer after previous surgery and/or radiotherapy Stage IIIB: T4 lesion due to malignant pleural effusion, OR multiple lesions in a single lobe containing a T3 or T4 primary, OR lesions in multiple lobes of the ipsilateral lung for which one such lesion is T3 or T4 Any N M0 Stage IV: Any T, Any N, M1 Measurable or evaluable disease Measurable or evaluable disease must be outside of the prior radiotherapy port or prior surgical resection area No brain metastases No bronchoalveolar carcinoma or stage IIIB tumor involving the superior sulcus (pancoast tumors)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine no greater than 2 times upper limit of normal AND Creatinine clearance at least 50 mL/min Other: No prior malignancy in the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently in complete remission Not pregnant or nursing Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for non-small cell lung cancer No concurrent biologic therapy to measurable or evaluable lesions Chemotherapy: No prior systemic chemotherapy for non-small cell lung cancer Endocrine therapy: No concurrent hormonal therapy to measurable or evaluable lesions Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No concurrent radiotherapy to measurable lesions Palliative radiation to small field nonmeasurable sites of disease (painful bony metastases) allowed Surgery: At least 3 weeks since surgery (thoracic or other major surgeries) and recovered

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

carboplatin/gemcitabine/paclitaxel

Experimental group

Description:

IV carboplatin AUC=5.5 day 1 every 21 days X 3 IV gemcitabine 1,000 mg/m\^2/day, days 1 and 8 every 21 days X3 IV paclitaxel 225 mg/m\^2/day, day 1 every 21 days X 3

Treatment:

Drug: paclitaxel

Drug: carboplatin

Drug: gemcitabine

cisplatin/vinorelbine/docetaxel

Experimental group

Description:

IV cisplatin 100 mg/m\^2 day 1 every 21 days X 3 IV vinorelbine 25 mg/m\^2/day, days 1 and 8 every 21 days X 3 IV docetaxel 75 mg/m\^2 day 1 every 21 days X 3

Treatment:

Drug: docetaxel

Drug: cisplatin

Drug: vinorelbine