Celecoxib in Managing Pain, Weight Loss, and Weakness in Patients With Advanced Cancer - Full Text View

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:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fungal Infections Hodgkin Disease Kaposi's Sarcoma Leukemia Lymphoma Melanoma Nutritional Support Ovarian Cancer Soft Tissue Sarcoma Weight Control

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:

296

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093678

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Donald P. Lawrence, MD	Tufts Medical Center
Investigator:	Michael J. Fisch, MD, MPH, FACP	M.D. Anderson Cancer Center

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 February 09, 2012