Clinical trial NCT00093678: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cachexia
Lymphoma
Melanoma (Skin)
Ovarian Cancer
Pain
Sarcoma
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: 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
stage III small lymphocytic lymphoma
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma
intraocular lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
primary central nervous system lymphoma
recurrent adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
Waldenstrom macroglobulinemia
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
adult grade III lymphomatoid granulomatosis
recurrent adult grade III lymphomatoid granulomatosis
recurrent mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
recurrent adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma
immunosuppressive treatment related Kaposi sarcoma
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tufts Medical Center
name: Donald P. Lawrence, MD
role: STUDY_CHAIR
affiliation: M.D. Anderson Cancer Center
name: Michael J. Fisch, MD, MPH, FACP
References: