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) - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00040885

Purpose

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)

Condition	Intervention	Phase
Anorexia Cachexia Fatigue Lung Cancer	Biological: infliximab Drug: docetaxel Procedure: fatigue assessment and management	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fatigue Lung Cancer Weight Control

Drug Information available for: Docetaxel Infliximab

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Assessment of weight
Rate of weight change

Secondary Outcome Measures:

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

Study Start Date:	October 2002
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Detailed Description:

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 (infliximab treatment discontinued effective 10/05/05).
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 (infliximab treatment discontinued effective 10/05/05).

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.

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 older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040885

Show 188 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Aminah Jatoi, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Jatoi 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. Epub 2009 Aug 8.

ClinicalTrials.gov Identifier:	NCT00040885 History of Changes
Other Study ID Numbers:	CDR0000069417, NCCTG-N01C9, NCI-P02-0226
Study First Received:	July 8, 2002
Last Updated:	September 22, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

fatigue
anorexia
cachexia

Additional relevant MeSH terms:

Anorexia
Cachexia
Carcinoma, Non-Small-Cell Lung
Fatigue
Lung Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Infliximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012