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


N/A
18 Years
N/A
Not Enrolling
Both
Cachexia, Lymphoma, Melanoma (Skin), Ovarian Cancer, Pain, Sarcoma, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Donald P. Lawrence, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Tufts Medical Center

Authority:

Unspecified

Study ID:

CDR0000389434

NCT ID:

NCT00093678

Start Date:

Completion Date:

Related Keywords:

  • Cachexia
  • Lymphoma
  • Melanoma (Skin)
  • Ovarian Cancer
  • Pain
  • Sarcoma
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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
  • Cachexia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Melanoma
  • Ovarian Neoplasms
  • Lymphoma, Large-Cell, Immunoblastic
  • Sarcoma

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