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Valdecoxib in Treating Chronic Pain in Cancer Patients Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Valdecoxib in Treating Chronic Pain in Cancer Patients conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Valdecoxib in Treating Chronic Pain in Cancer Patients Clinical research trials and Valdecoxib in Treating Chronic Pain in Cancer Patients medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Valdecoxib in Treating Chronic Pain in Cancer Patients. Valdecoxib in Treating Chronic Pain in Cancer Patients Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Valdecoxib in Treating Chronic Pain in Cancer Patients clinical trial. Subjects often receive the most expert healthcare possible for their Valdecoxib in Treating Chronic Pain in Cancer Patients condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Valdecoxib in Treating Chronic Pain in Cancer Patients  Valdecoxib in Treating Chronic Pain in Cancer Patients
Valdecoxib in Treating Chronic Pain in Cancer Patients
For Condition: Pain,unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): Dana-Farber/Harvard Cancer Center ,
Synopsis: RATIONALE: Valdecoxib may be effective in relieving chronic pain in cancer patients. It is not yet known if valdecoxib is effective in treating chronic pain. PURPOSE: Randomized clinical trial to study the effectiveness of valdecoxib in relieving chronic pain in cancer patients.
Details: OBJECTIVES: I. Assess the analgesic efficacy of valdecoxib administered in addition to opioid medication in patients with chronic pain due to cancer or prior cancer therapy. II. Assess the safety of this drug in these patients. PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to baseline average pain intensity score (2-4 vs 5-11). Patients are randomized to 1 of 2 treatment arms. Patients undergo a pretreatment period of 3-14 days to determine daily dose of sustained release and immediate release opioid medications required to adequately control pain with tolerable side effects. Arm I: Patients receive oral valdecoxib twice daily in addition to opioid medications. Arm II: Patients receive oral placebo twice daily in addition to opioid medications. Treatment continues for a maximum of 12 weeks in the absence of inadequate pain control or unacceptable toxicity. Patients record daily pain assessments and total daily opioid consumption. Patients also are contacted by telephone weekly for assessment of pain, opioid use, and adverse effects. PROJECTED ACCRUAL: A maximum of 260 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Chronic visceral or somatic pain due to cancer or prior cancer therapy; No pain primarily classified as neuropathic or unknown in nature - Required opioid analgesic at least 5 days/week for at least 2 weeks prior to study - Expectation of continued requirement for daily opioid medication (morphine sulfate, oxycodone, or hydromorphone) --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 3 weeks since initiation of new chemotherapy agent; No concurrent participation in an investigational chemotherapy trial - Endocrine therapy: At least 2 weeks since initiation of corticosteroids as an analgesic adjuvant - Radiotherapy: At least 4 weeks since prior radiopharmaceutical therapy or radiotherapy; No concurrent radiopharmaceutical therapy or radiotherapy - Surgery: No concurrent therapeutic procedure (e.g., surgery or biopsy) that would affect pain intensity - Other: No prior participation on this study; At least 30 days since prior investigational agent; At least 30 days since prior treatment for esophageal, gastric, pyloric channel, or duodenal ulcer; At least 8 weeks since initiation of bisphosphonates; At least 2 weeks since anticancer therapy that would affect study evaluation; At least 2 weeks since initiation of antidepressants, anti-epilepsy drugs, or antihistamines as an analgesic adjuvant; At least 5 half-lives since prior specific COX-2 inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs); No concurrent other investigational agent; No concurrent anticancer therapy that would affect study evaluation; No concurrent other analgesics, specific COX-2 inhibitors, or NSAIDs except as specifically permitted on study; Concurrent acetaminophen less than 2 g/day allowed if given 2 days or fewer per week; Concurrent acetylsalicylic acid no greater than 325 mg/day allowed --Patient Characteristics-- - Age: Legal age and over - Performance status: Karnofsky 60-100% - Life expectancy: At least 4 months - Hematopoietic: Platelet count at least 40,000/mm3; No platelet function disorder - Hepatic: No known significant hepatic insufficiency - Renal: Creatinine less than 1.5 mg/dL; BUN less than 1.5 times upper limit of normal; Creatinine clearance greater than 50 mL/min; No known renal insufficiency - Gastrointestinal: No diagnosis of esophageal, gastric, pyloric channel, or duodenal ulceration within the past 30 days; No history of esophageal or gastric cancer; No intractable nausea or vomiting; No inability to swallow tablets or to tolerate oral medication - Other: Weight at least 50 kg; No AIDS or AIDS-related cancers; No history of hypersensitivity to cyclooxygenase inhibitors (e.g., NSAIDs or specific COX-2 inhibitors) or opiates; No significant alcohol, analgesic, or narcotic substance abuse within the past 6 months; No history of unstable disease or condition that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SusanaCampos, Study Chair, Dana-Farber/Harvard Cancer Center
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: CDR0000068670; DFCI-N91-00-02-040,BWH-2000-P-000984/7,SC-N91-00-02-040
Study Start Date: January 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021996
Other Pain Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
2. SU5416 and Paclitaxel in Treating Patients With Advanced Cancer
3. LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors
4. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors
5. Darbepoetin alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy
Related Studies:
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Valdecoxib in Treating Chronic Pain in Cancer Patients
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