Clinical Trial: Docetaxel With or Without Infliximab in Treating Weight Loss, Loss of Appetite, and Fatigue in Patients With Unresectable Non-Small Cell Lung Cancer (Infliximab Treatment Discontinued Effective 10/05/05)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Docetaxel And Infliximab/Placebo In Non-Small Cell Lung Cancer (NSCLC) Patients Greater Than Or Equal To 65 Years Of Age Or In NSCLC Patients With Poor Performance Status: A Double-Blind Randomized, P

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Infliximab may improve cancer-related weight loss, lack of appetite, and fatigue. It is not yet known whether docetaxel is more effective with or without infliximab in preventing weight loss and fatigue in patients with advanced cancer. (Infliximab treatment discontinued effective 10/05/05)

PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel with or without infliximab in preventing weight loss, loss of appetite, and fatigue in patients who have unresectable non-small cell lung cancer. (Infliximab treatment discontinued effective 10/05/05)


Detailed Summary:

OBJECTIVES:

  • Compare the improvement or stabilization of weight in elderly or poor performance status patients with unresectable non-small cell lung cancer treated with docetaxel with or without infliximab (infliximab treatment discontinued effective 10/05/05).
  • Compare appetite and functional status in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the augmentation or maintenance of lean tissue in patients treated with these regimens.
  • Compare the response rates and time to disease progression in patients treated with these regimens.
  • Compare the survival of patients treated with these regimens.
  • Determine whether the tumor necrosis factor-alpha polymorphisms in the -308 and -238 regions predict which cancer patients will experience loss of appetite and weight and which patients might potentially benefit from infliximab (infliximab treatment discontinued effective 10/05/05).

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to weight loss within the past 6 months (0% vs more than 0% to less than 5% vs at least 5%), number of prior chemotherapy regimens (0 vs 1 vs more than 1), gender, and GBU prognostic index (good vs bad vs unsure).

  • Part A (non-randomized, single-center portion of study): Five patients receive infliximab IV (infliximab treatment discontinued effective 10/05/05) over 2 hours once weekly on weeks 1, 3, and 5 of the first course and once weekly on weeks 1 and 5 of
    Sponsor: Alliance for Clinical Trials in Oncology

    Current Primary Outcome:

    • Assessment of weight [ Time Frame: Up to 5 years ]
    • Rate of weight change [ Time Frame: Up to 5 years ]


    Original Primary Outcome:

    Current Secondary Outcome:

    • Overall survival [ Time Frame: Up to 5 years ]
    • Incidence of treatment-related toxicity [ Time Frame: Up to 5 years ]
    • Cancer-related fatigue as measured by the Brief Fatigue Inventory [ Time Frame: Up to 5 years ]
    • Time-to-weight decline [ Time Frame: Up to 5 years ]
    • Appetite [ Time Frame: Up to 5 years ]
    • Lean tissue changes [ Time Frame: Up to 5 years ]
    • Quality of life [ Time Frame: Up to 5 years ]


    Original Secondary Outcome:

    Information By: Alliance for Clinical Trials in Oncology

    Dates:
    Date Received: July 8, 2002
    Date Started: October 2002
    Date Completion:
    Last Updated: December 5, 2016
    Last Verified: December 2016