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

This study is currently recruiting patients.

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE:

PURPOSE: 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.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.

Condition Treatment or Intervention Phase
Anorexia
Cachexia
Fatigue
Non-small cell lung cancer
 Drug: docetaxel
 Drug: infliximab
 Procedure: anticachectic therapy
 Procedure: chemotherapy
 Procedure: fatigue assessment/management
 Procedure: nutritional support
 Procedure: supportive care/therapy
Phase III

MedlinePlus related topics:  Eating Disorders;   Lung Cancer;   Weight Loss and Dieting

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Docetaxel With or Without Infliximab in Elderly or Poor Performance Status Patients With Wasting, Anorexia, and Asthenia Related to Unresectable Non-Small Cell Lung Cancer

Further Study Details: 

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.
  • 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.

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).

  • Five patients receive infliximab IV over 2 hours once weekly on weeks 1, 3, and 5 of the first course and once weekly on weeks 1 and 5 of all subsequent courses and docetaxel IV over 1 hour (immediately after completion of infliximab infusion) once weekly on weeks 1-6 of each course. Treatment repeats every 8 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients may continue infliximab (even if docetaxel is discontinued or other chemotherapy is initiated) as long as beneficial effects are observed. If none of the 5 patients experiences any grade 4 or 5 toxicity directly attributable to infliximab, additional patients are accrued for part B of the study.
  • Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive infliximab and docetaxel as in part A.
  • Patients receive docetaxel as in part A and placebo IV over 2 hours according to the infliximab schedule in part A. Treatment in both arms repeats as in part A. Patients may continue infliximab/placebo (even if docetaxel is discontinued or other chemotherapy is initiated) as long as beneficial effects are observed.

Quality of life, fatigue, appetite/anorexia, cachexia, and weight are assessed at baseline, weekly on weeks 1-8, and then monthly for the remainder of study treatment.

Patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this study within 3 years.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age:

  • See Disease Characteristics
  • Adult

Performance status:

  • See Disease Characteristics
  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic:

  • Bilirubin normal
  • AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase less than ULN OR
  • Alkaline phosphatase ≤ 4 times ULN if ALT less than ULN
  • No ascites

Renal:

  • Creatinine ≤ 1.5 times ULN

Cardiovascular:

  • No prior or concurrent congestive heart failure

Pulmonary:

Other:

  • No prior anaphylactic reaction to any taxane
  • No known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (more than 5 episodes per week)
  • No infection or chronic debilitating illness that would increase the risk of chemotherapy administration
  • No grade 2 or greater peripheral neuropathy of any etiology
  • No edema
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
  • Alert and mentally competent
  • Able to complete questionnaires alone or with assistance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

Endocrine therapy:

  • At least 1 month since prior adrenal steroids, androgens, progestational agents, or appetite stimulants
  • No concurrent adrenal steroids, androgens, progestational agents, or appetite stimulants unless needed (e.g., steroids for CNS metastases)
  • Concurrent inhaled, topical, or optical steroids allowed
  • Concurrent short-term dexamethasone around days of chemotherapy administration allowed for protection against anaphylaxis and emesis

Radiotherapy:

  • More than 3 weeks since prior radiotherapy
  • No prior radiotherapy to more than 25% of bone marrow

Surgery:

  • More than 3 weeks since prior major surgery

Other:


Location and Contact Information


Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States; Recruiting
Tom Robert Fitch, MD  480-301-9875 

Florida
      Mayo Clinic - Jacksonville, Jacksonville,  Florida,  32224,  United States; Recruiting
Edith A. Perez, MD  904-953-7283    perez.edith@mayo.edu 

Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
Kendrith M. Rowland, MD  217-383-4083    kendrith.rowland@carle.com 

      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61615-7828,  United States; Recruiting
John W. Kugler, MD  309-243-3605 

Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States; Recruiting
Martin Wiesenfeld, MD  319-363-8303 

      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-244-7586 

      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States; Recruiting
Donald Bruce Wender, MD, PhD  712-252-0088    shoaresearch@shoa-research.org 

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
Shaker R. Dakhil, MD, FACP  316-268-5784 

Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States; Recruiting
Daniel Nikcevich, MD, PhD  218-786-3625    dnikcevich@smdc.org 

      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
Patrick J. Flynn, MD  952-993-1517    patrick.flynn@usoncology.com 

      Coborn Cancer Center, Saint Cloud,  Minnesota,  56303,  United States; Recruiting
Harold E. Windschitl, MD  320-229-5199    windschitlh@centracare.com 

      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Aminah Jatoi, MD  507-284-2511 

Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
James A. Mailliard, MD  402-280-4364    jamailliard@mrcc.cc 

North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States; Recruiting
Preston D. Steen, MD  701-234-6298    prestonsteen@meritcare.com 

      Medcenter One Health System, Bismarck,  North Dakota,  58501-5505,  United States; Recruiting
Edward J. Wos, DO  701-323-5741    ejwos@mohs.org 

Ohio
      CCOP - Dayton, Dayton,  Ohio,  45429,  United States; Recruiting
Howard M. Gross, MD  937-832-1093 

Oklahoma
      CCOP - Oklahoma, Tulsa,  Oklahoma,  74136,  United States; Recruiting
Mark Olsen, MD, PhD  918-499-2000    markolsen@usoncology.com 

Pennsylvania
      Allegheny General Hospital, Pittsburgh,  Pennsylvania,  15212-4772,  United States; Recruiting
Jane Raymond, MD  412-359-8366 

      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
Albert M. Bernath, MD  570-271-6466 

South Carolina
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States; Recruiting
James Dewitt Bearden, MD  864-560-7050 

South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States; Recruiting
Loren K. Tschetter, MD  605-328-8044    tidemanb@siouxvalley.org 

      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States; Recruiting
Larry P. Ebbert, MD  605-341-8704 

Wisconsin
      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54301,  United States; Recruiting
Anthony J. Jaslowski, MD  920-884-3135    tjaslowski@gboncology.com 

Study chairs or principal investigators

Aminah Jatoi, MD,  Study Chair,  Mayo Clinic Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000069417; NCCTG-N01C9; NCI-P02-0226; NCT00040885
Record last reviewed:  September 2004
Last Updated:  April 4, 2005
Record first received:  July 8, 2002
ClinicalTrials.gov Identifier:  NCT00040885
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005