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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00093678
First received: October 6, 2004
Last updated: January 24, 2008
Last verified: January 2006
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Eastern Cooperative Oncology Group
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
Melanoma
Ovarian Neoplasms
Sarcoma
Adnexal Diseases
Body Weight
Body Weight Changes
Emaciation
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Ovarian Diseases
Signs and Symptoms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014