CachexiaNCT00093678
Celecoxib in Managing Pain, Weight Loss, and Weakness in Patients With Advanced Cancer
A study testing celecoxib, anticachectic therapy and nutritional support in people with Cachexia and Lymphoma, run by Eastern Cooperative Oncology Group.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cachexia, Lymphoma, Melanoma (Skin)
- What is being tested?
- celecoxib, anticachectic therapy and nutritional support
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib in Patients With Advanced Cancer
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.
Read the 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.
- Conditions
- Cachexia, Lymphoma, Melanoma (Skin), Ovarian Cancer, Pain, Sarcoma
- Being tested
- celecoxib, anticachectic therapy, nutritional support, pain therapy, supportive care/therapy
- 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
- Medical subject headings
- Cachexia, Lymphoma, Melanoma, Ovarian Neoplasms, Pain, Sarcoma, Chondrosarcoma, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
anticachectic therapyProcedure or surgery
nutritional supportProcedure or surgery
pain therapyProcedure or surgery
supportive care/therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Donald P. Lawrence, MD, Study chair, Tufts Medical CenterMichael J. Fisch, MD, MPH, FACP, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093678
- Sponsor's protocol ID
- CDR0000389434
- Other IDs
- ECOG-E1Z02
- Status last verified
- Oct 2015
- First submitted
- 6 Oct 2004
- Last updated
- 8 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00093678
- Acronym / sponsor ID
- CDR0000389434
- Conditions
- Cachexia, Lymphoma, Melanoma (Skin), Ovarian Cancer, Pain, Sarcoma
- 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
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 8 Oct 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| celecoxib | Drug | – |
| anticachectic therapy | Procedure or surgery | – |
| nutritional support | Procedure or surgery | – |
| pain therapy | Procedure or surgery | – |
| supportive care/therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald P. Lawrence, MD study chair
Tufts Medical Center
Michael J. Fisch, MD, MPH, FACP
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing celecoxib, anticachectic therapy and nutritional support in people with Cachexia and Lymphoma, run by Eastern Cooperative Oncology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015.