- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00093678
Celecoxib in Managing Pain, Weight Loss, and Weakness in Patients With Advanced Cancer
A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib in Patients With Advanced Cancer
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.
Study Overview
Status
Conditions
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 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.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Donald P. Lawrence, MD, Tufts Medical Center
- Michael J. Fisch, MD, MPH, FACP, M.D. Anderson Cancer Center
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- unspecified adult solid tumor, protocol specific
- pain
- chondrosarcoma
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- recurrent melanoma
- stage IV melanoma
- AIDS-related peripheral/systemic lymphoma
- recurrent adult Hodgkin lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- cachexia
- Waldenstrom macroglobulinemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent mantle cell lymphoma
- stage III melanoma
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- intraocular lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- adult grade III lymphomatoid granulomatosis
- recurrent adult grade III lymphomatoid granulomatosis
- stage IV adult soft tissue sarcoma
- recurrent adult soft tissue sarcoma
- stage IV uterine sarcoma
- recurrent uterine sarcoma
- ovarian sarcoma
- stage III uterine sarcoma
- metastatic osteosarcoma
- recurrent osteosarcoma
- stage III adult soft tissue sarcoma
- classic Kaposi sarcoma
- AIDS-related Kaposi sarcoma
- recurrent Kaposi sarcoma
- primary central nervous system lymphoma
- AIDS-related primary CNS lymphoma
- immunosuppressive treatment related Kaposi sarcoma
Additional Relevant MeSH Terms
- Metabolic Diseases
- Immune System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Nutrition Disorders
- Body Weight
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Body Weight Changes
- Neuroendocrine Tumors
- Nevi and Melanomas
- Emaciation
- Weight Loss
- Sarcoma
- Lymphoma
- Melanoma
- Wasting Syndrome
- Cachexia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Celecoxib
Other Study ID Numbers
- CDR0000389434
- ECOG-E1Z02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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