Clinical trial · Interventional
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)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anorexia | — | UNRESOLVED | — |
| Cachexia | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| infliximab | Biological | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- infliximab + docetaxel
- description
- 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. 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.
- interventionNames
- Biological: infliximab
- Drug: docetaxel
- type
- ACTIVE_COMPARATOR
- label
- placebo + docetaxel
- description
- Patients receive docetaxel IV over 1 hour (immediately after completion of infliximab infusion once weekly on weeks 1-6 of each course. Patients receive placebo 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. Treatment repeats every 8 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTJatoi A, Ritter HL, Dueck A, Nguyen PL, Nikcevich DA, Luyun RF, Mattar BI, Loprinzi CL. A placebo-controlled, double-blind trial of infliximab for cancer-associated weight loss in elderly and/or poor performance non-small cell lung cancer patients (N01C9). Lung Cancer. 2010 May;68(2):234-9. doi: 10.1016/j.lungcan.2009.06.020. Epub 2009 Aug 8. PMID 19665818