Celecoxib in Managing Pain, Weight Loss, and Weakness in Patients With Advanced Cancer

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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: This randomized clinical trial is studying celecoxib to see how well it works in managing pain, weight loss, and weakness in patients with advanced cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Celecoxib

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