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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

Phase 3
18 Years
Not Enrolling
Anorexia, Cachexia, Fatigue, Lung Cancer

Thank you

Trial Information

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


- 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

- 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.

Inclusion Criteria


- 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



- See Disease Characteristics

- Adult

Performance status:

- See Disease Characteristics

- ECOG 0-2

Life expectancy:

- At least 3 months


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- 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


- Creatinine ≤ 1.5 times ULN


- No prior or concurrent congestive heart failure


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


- 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


Biologic therapy:

- Not specified


- 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


- More than 3 weeks since prior radiotherapy

- No prior radiotherapy to more than 25% of bone marrow


- More than 3 weeks since prior major surgery


- More than 3 weeks since other prior antineoplastic therapy

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Assessment of weight

Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

October 2002

Completion Date:

Related Keywords:

  • Anorexia
  • Cachexia
  • Fatigue
  • Lung Cancer
  • 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
  • Anorexia
  • Cachexia
  • Carcinoma, Non-Small-Cell Lung
  • Fatigue
  • Lung Neoplasms



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