Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and inner ear damage) caused by chemotherapy.

PURPOSE: This randomized phase II trial is studying giving docetaxel and cisplatin together with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: 2,2'-dithiodiethanesulfonic acid; Cisplatin; Darbepoetin alfa; Docetaxel; Mesna

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed* non-small cell lung cancer of 1 of the following subtypes:

• Squamous carcinoma

• Basaloid carcinoma

• Adenocarcinoma

• Bronchoalveolar carcinoma

• Adenosquamous carcinoma

• Large cell carcinoma

• Large cell neuroendocrine carcinoma

• Giant cell carcinoma

• Sarcomatoid carcinoma

• Non-small cell carcinoma not otherwise specified NOTE: *Histologic or cytologic confirmation of recurrence is required for patients who have undergone prior complete resection

• Stage IIIB disease due to malignant pleural effusion OR stage IV disease

• Measurable disease

• At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

• The following are considered nonmeasurable disease:

• Bone lesions

• Brain metastases or leptomeningeal disease

• Ascites

• Pleural/pericardial effusion

• Abdominal masses not confirmed and followed by imaging techniques

• Cystic lesions

• Tumor lesions situated in a previously irradiated area

• Brain metastases are allowed provided patient is neurologically stable and off steroids

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 mg/dL

• AST ≤ 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• Creatinine ≤ ULN

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No grade 2 or greater neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No other concurrent growth factors

Chemotherapy

• No prior chemotherapy

• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics

• No concurrent hormonal therapy except steroids administered for adrenal failure, hormones for non-cancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic

Radiotherapy

• See Disease Characteristics

• Prior radiotherapy allowed for brain metastases only

• No concurrent palliative radiotherapy

Surgery

• See Disease Characteristics