Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Condition: Anemia; Drug/Agent Toxicity by Tissue/Organ; Lung Cancer; Neutropenia
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neutropenia; Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the incidence and severity of peripheral neuropathy in patients with stage IIIB
           or IV non-small cell lung cancer treated with docetaxel and cisplatin with or without
           dimesna.

        -  Compare the feasibility of these regimens, in terms of febrile neutropenia and treatment
           delays, in these patients.

        -  Compare the objective response rate in patients treated with these regimens.

      Secondary

        -  Compare the survival and failure-free survival of patients treated with these regimens.

        -  Compare the toxicity profile of these regimens in these patients.

        -  Compare the incidence and severity of cisplatin-induced nephrotoxicity in patients
           treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
      arms.

        -  Arm I*: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1
           and pegfilgrastim subcutaneously (SC) on day 2.

        -  Arm II*: Patients receive docetaxel, cisplatin, and pegfilgrastim as in arm I and
           dimesna IV over 30 minutes on day 1.

      NOTE: *In both arms, darbepoetin alfa is administered SC on day 1 of each course for
      hemoglobin ≤ 11 g/dL.

      In both arms, treatment repeats every 2 weeks for a total of 6 courses in the absence of
      disease progression or unacceptable toxicity.

      Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
    

Intervention name(s): darbepoetin alfa; pegfilgrastim; cisplatin; docetaxel; BNP7787
Intervention type(s): Biological; Biological; Drug; Drug; Drug
Intervention description(s): 200 mcg sub Q on day 1 of each cycle if HgB < or = 11 g/dL; 6 mg sub Q day 2 of each cycle; 75 mg/sq m IV over 1 hr Day 1 of each cycle; 75 mg/sq m IV over 1 hr Day 1 of each cycle; 40 g IV over 30 min Day 1 of each cycle
Intervention MeSH terms: Docetaxel; Darbepoetin alfa; 2,2'-dithiodiethanesulfonic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: drug/agent toxicity by tissue/organ; anemia; neutropenia; stage IV non-small cell lung cancer; stage IIIB non-small cell lung cancer; recurrent non-small cell lung cancer; squamous cell lung cancer; large cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer; adenosquamous cell lung cancer