Status:
WITHDRAWN
Celecoxib in Managing Pain, Weight Loss, and Weakness in Patients With Advanced Cancer
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cachexia
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief 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 clinica...
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00093678
Last Update
October 8 2015
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