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)
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)
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 7, 2016 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Supportive Care
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Biological: infliximab; Drug: docetaxel; Other: placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona
- Aurora Presbyterian HospitalAurora, Colorado
- Boulder Community HospitalBoulder, Colorado
- Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado
- Porter Adventist HospitalDenver, Colorado
- Presbyterian - St. Luke's Medical CenterDenver, Colorado
- St. Joseph HospitalDenver, Colorado
- Rose Medical CenterDenver, Colorado
- CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado
- Swedish Medical CenterEnglewood, Colorado
- Sky Ridge Medical CenterLone Tree, Colorado
- Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 7, 2016. Always confirm current availability with the study team.