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)

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel; Infliximab

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

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:

• 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

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