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

Original Study ID : CDR0000389434

Secondary ID : ECOG-E1Z02

NCT ID : NCT00093678

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

Official Title : A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib in Patients With Advanced Cancer

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.

Source : National Cancer Institute (NCI)

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.

Overall Status : Withdrawn

Official Title : N/A

Phase : Interventional

Study Design : Supportive Care, Randomized, Double-Blind, Placebo Control

Enrollment : 296

Verification Date : January 2006

First Received Date : October 6, 2004

Trial Eligibility

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

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Clinical Trial Name -Celecoxib in Managing Pain, Weight Loss, and Weakness in Patients With Advanced Cancer