|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00093678 |
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: | Supportive Care, Randomized, Double-Blind, Placebo Control |
| Official Title: | A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib in Patients With Advanced Cancer |
| Estimated Enrollment: | 296 |
OBJECTIVES:
Primary
Secondary
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.
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:
Clear evidence of residual disease after most recent prior treatment
Brain metastases allowed provided the following criteria are met:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
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:
Radiotherapy
Surgery
Other
Contacts and Locations
More Information
| Study ID Numbers: | CDR0000389434, ECOG-E1Z02 |
| Study First Received: | October 6, 2004 |
| Last Updated: | January 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00093678 History of Changes |
| Health Authority: | Unspecified |
|
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 |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Gonadal Disorders Physiological Effects of Drugs Neoplasms, Nerve Tissue Cachexia Urogenital Neoplasms Ovarian Diseases Melanoma Genital Diseases, Female Body Weight Neoplasms, Connective and Soft Tissue Signs and Symptoms Neoplasms by Site Sensory System Agents |
Therapeutic Uses Neoplasms, Germ Cell and Embryonal Weight Loss Lymphoma, Large-Cell, Immunoblastic Body Weight Changes Anti-Inflammatory Agents, Non-Steroidal Nevi and Melanomas Analgesics Lymphoma Endocrine Gland Neoplasms Celecoxib Neoplasms by Histologic Type Ovarian Neoplasms Immunoproliferative Disorders Immune System Diseases |