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.

Official Title

Randomized Study of Celecoxib for the Management of Pain and Cachexia in Patients With Advanced Cancer

Conditions

– Cachexia- Cancer- Pain

Study Type

Interventional

Study Design

Treatment

Further Details

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 ¡Ý 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.

Study Start

Eligibility & Criteria

18 years or older, male or female- 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

Total Enrolment

Contact Details

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