Celecoxib in Managing Pain, Weight Loss, and Weakness in Patients With Advanced Cancer
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cachexia Lymphoma Melanoma (Skin) Ovarian Cancer Pain Sarcoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: celecoxib Procedure: anticachectic therapy Procedure: nutritional support Procedure: pain therapy Procedure: supportive care/therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib in Patients With Advanced Cancer |
| Estimated Enrollment: | 296 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00093678 History of Changes |
| Other Study ID Numbers: | CDR0000389434, ECOG-E1Z02 |
| Study First Received: | October 6, 2004 |
| Last Updated: | January 24, 2008 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
pain cachexia unspecified adult solid tumor, protocol specific recurrent uterine sarcoma stage III uterine sarcoma stage IV uterine sarcoma ovarian sarcoma recurrent adult soft tissue sarcoma stage III adult soft tissue sarcoma stage IV adult soft tissue sarcoma recurrent melanoma stage III melanoma stage IV melanoma chondrosarcoma metastatic osteosarcoma |
recurrent osteosarcoma classic Kaposi sarcoma AIDS-related Kaposi sarcoma recurrent Kaposi sarcoma stage III adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III mantle cell lymphoma stage III marginal zone lymphoma |
Additional relevant MeSH terms:
|
Cachexia Lymphoma Lymphoma, Non-Hodgkin Melanoma Ovarian Neoplasms Lymphoma, Large-Cell, Immunoblastic Sarcoma Emaciation Weight Loss Body Weight Changes Body Weight Signs and Symptoms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013