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Celecoxib in Managing Pain, Weight Loss, and Weakness in Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00093678
Recruitment Status : Withdrawn
First Posted : October 8, 2004
Last Update Posted : October 8, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Eastern Cooperative Oncology Group

Study Description
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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 clinical trial is studying celecoxib to see how well it works in managing pain, weight loss, and weakness in patients with advanced cancer.


Condition or disease Intervention/treatment Phase
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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Official Title: A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib in Patients With Advanced Cancer

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
Drug Information available for: Celecoxib
Genetic and Rare Diseases Information Center resources: Soft Tissue Sarcoma Ovarian Cancer Ovarian Epithelial Cancer Lymphosarcoma B-cell Lymphoma Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Follicular Lymphoma Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Cutaneous T-cell Lymphoma Diffuse Large B-Cell Lymphoma Leukemia, T-cell, Chronic Adult T-cell Leukemia/lymphoma Waldenstrom Macroglobulinemia Mycosis Fungoides Osteosarcoma Primary Central Nervous System Lymphoma Hodgkin Lymphoma Marginal Zone Lymphoma Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Sezary Syndrome Uterine Sarcoma Kaposi Sarcoma Burkitt Lymphoma Anaplastic Large Cell Lymphoma Chondrosarcoma Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Lymphomatoid Granulomatosis Neuroendocrine Tumor Neuroepithelioma

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00093678


Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Donald P. Lawrence, MD Tufts Medical Center
OverallOfficial: Michael J. Fisch, MD, MPH, FACP M.D. Anderson Cancer Center
More Information
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ClinicalTrials.gov Identifier: NCT00093678    
Other Study ID Numbers: CDR0000389434
ECOG-E1Z02
First Posted: October 8, 2004    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015
Keywords provided by Eastern Cooperative Oncology Group:
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:
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Lymphoma
Melanoma
Sarcoma
Wasting Syndrome
Cachexia
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
Neoplasms, Connective and Soft Tissue
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs