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

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Primary Purpose

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

celecoxib

anticachectic therapy

nutritional support

pain therapy

supportive care/therapy

About this trial

This is an interventional supportive care trial for Cachexia focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00093678

First Posted

October 6, 2004

Last Updated

October 6, 2015

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Withdrawn

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Masking

Double

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

celecoxib

Intervention Type

Procedure

Intervention Name(s)

anticachectic therapy

Intervention Type

Procedure

Intervention Name(s)

nutritional support

Intervention Type

Procedure

Intervention Name(s)

pain therapy

Intervention Type

Procedure

Intervention Name(s)

supportive care/therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald P. Lawrence, MD

Organizational Affiliation

Tufts Medical Center

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Michael J. Fisch, MD, MPH, FACP

Organizational Affiliation

M.D. Anderson Cancer Center

Cachexia, Lymphoma, Melanoma (Skin)

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial