Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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)

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care, Treatment Completed Adult NCI NCCTG-N01C9 NCI-P02-0226, N01C9, NCT00040885

Objectives

1. 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).
2. Compare appetite and functional status in patients treated with these regimens.
3. Compare the toxicity of these regimens in these patients.
4. Compare the augmentation or maintenance of lean tissue in patients treated with these regimens.
5. Compare the response rates and time to disease progression in patients treated with these regimens.
6. Compare the survival of patients treated with these regimens.
7. 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).

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed unresectable non-small cell lung cancer that is considered incurable with other therapies



• Chemotherapy naive or previously treated disease



• Meets one of the following criteria:
  • Age 65 and over with ECOG performance status of 0-2
  • Under age 65 with ECOG performance status of 2



• No symptomatic or known untreated brain metastases

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics
• No prior docetaxel for metastatic non-small cell lung cancer

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:

• More than 3 weeks since other prior antineoplastic therapy

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/mm³
• Platelet count ≥ 100,000/mm³

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:

• No prior tuberculosis or positive purified protein derivative skin test (tuberculin test)

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

Expected Enrollment

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

Outcomes

Assessment of weight
Rate of weight change

Overall survival
Incidence of treatment-related toxicity
Cancer-related fatigue as measured by the Brief Fatigue Inventory
Time-to-weight decline
Appetite
Lean tissue changes
Quality of life

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 all subsequent courses and docetaxel IV over 1 hour (immediately after completion of infliximab infusion [infliximab treatment discontinued effective 10/05/05]) 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.

  If none of the 5 patients experiences any grade 4 or 5 toxicity directly attributable to infliximab (infliximab treatment discontinued effective 10/05/05), additional patients are accrued for part B of the study.




• Part B (randomized, multicenter portion of study): Patients are randomized to 1 of 2 treatment arms.
  • Arm I (infliximab treatment discontinued effective 10/05/05): Patients receive infliximab and docetaxel as in part A.
  
  
  
  • Arm II: Patients receive docetaxel as in part A and placebo IV over 2 hours according to the infliximab schedule in part A (infliximab treatment discontinued effective 10/05/05).

    Treatment in both arms repeats as in part A.

  
  
  

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Aminah Jatoi, MD, Protocol chair		Ph: 507-284-2511

Registry Information
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, Placebo-Controlled Trial To Prevent And Treat Wasting, Anorexia, And Asthenia In Chemotherapy-Naive And Previously-Treated Patients
Trial Start Date		2002-10-18
Registered in ClinicalTrials.gov		NCT00040885
Date Submitted to PDQ		2002-05-07
Information Last Verified		2008-10-10