RATIONALE: Celecoxib may help relieve moderate or severe pain associated with cancer. It may also decrease weight loss and improve muscle strength in cancer patients.

PURPOSE: Randomized clinical trial to study the effectiveness of celecoxib in managing pain, weight loss, and weakness in patients with advanced cancer.

Condition	Treatment or Intervention
Cachexia Cancer Pain	Drug: celecoxib  Procedure: anticachectic therapy  Procedure: nutritional support  Procedure: pain therapy  Procedure: supportive care/therapy

OBJECTIVES: Primary

• Compare the symptom burden and functional status, as measured by the physical well-being subscale of the Functional Assessment of Cancer Therapy-General (FACT-G), of patients with advanced cancer treated with celecoxib vs placebo.

Secondary

• Compare pain, as measured by the Brief Pain Inventory, in patients treated with these drugs.
• Compare the need for opioid analgesics, as measured by the oral morphine equivalent of analgesics used, in patients treated with these drugs.
• Compare weight loss in patients treated with these drugs.
• Compare quality of life, as measured by the FACT-G, in patients treated with these drugs.
• Compare the median survival of patients treated with these drugs.
• Determine the toxicity of celecoxib in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2 or 3), need for opioid analgesics within the past 2 weeks (yes vs no), and weight loss as percentage of baseline body weight (< 5% vs ≥ 5%). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral celecoxib twice daily.
• Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues in the absence of unacceptable toxicity.

Quality of life is assessed at baseline and at 2, 6, and 12 weeks.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 296 patients (148 per treatment arm) will be accrued for this study within 2 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed malignant tumor of 1 of the following types:
• Carcinoma
• Sarcoma
• Melanoma
• Lymphoma
• Metastatic or unresectable disease
• Clear evidence of residual disease after most recent prior treatment
• Measurable disease not required
• Patient has elected to receive supportive care only rather than active cancer treatment (e.g., palliative chemotherapy)
• Brain metastases allowed provided the following criteria are met:
• Completed treatment for CNS disease (e.g., whole brain radiotherapy, surgery, or stereotactic surgery)
• Clinically stable disease for at least 4 weeks after treatment completion
• No requirement for corticosteroids

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-3

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin ≤ 2 times upper limit of normal (ULN)
• ALT and AST ≤ 5 times ULN

Renal

• Creatinine ≤ 1.6 mg/dL

Cardiovascular

• No myocardial infarction within the past 6 months
• No transient ischemic attack within the past 6 months
• No stroke within the past 6 months
• No angina pectoris requiring medical therapy
• No other active coronary artery disease or cerebrovascular disease

Other

• No active gastrointestinal (GI) ulcer disease
• No GI bleeding
• No history of allergic reaction, urticaria, or bronchospasm after taking NSAIDs, aspirin, or sulfonamide drugs
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy

• Concurrent hematopoietic growth factors for cytopenia or fatigue allowed
• No concurrent biologic anticancer agents

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• See Disease Characteristics
• No concurrent corticosteroids for management of cancer-related symptoms or other illness
• No concurrent hormonal therapy
• Concurrent luteinizing hormone-releasing hormone therapy allowed for prostate cancer patients provided drug was initiated at least 6 months ago AND there is unequivocal evidence of progressive disease, defined by 1 of the following criteria:
• Rising prostate-specific antigen (PSA) on 3 successive measurements
• Rising PSA on 2 measurements taken at least 2 weeks apart
• New lesions on bone scan

Radiotherapy

• See Disease Characteristics

Surgery

• See Disease Characteristics

Other

• Concurrent bisphosphonates for management of osseous metastases or hypercalcemia allowed
• No concurrent cytotoxic drugs
• No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin

Study chairs or principal investigators

Donald P. Lawrence, MD,  Study Chair,  Tufts - New England Medical Center   
Michael J. Fisch, MD, MPH,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000389434; ECOG-E1Z02
Record last reviewed:  September 2004
Record first received:  October 6, 2004
ClinicalTrials.gov Identifier:  NCT00093678
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-20