Valdecoxib in Treating Chronic Pain in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00021996
Recruitment Status : Completed
First Posted : February 27, 2004
Last Update Posted : July 18, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Pain Unspecified Adult Solid Tumor, Protocol Specific Drug: valdecoxib Not Applicable

Detailed Description:

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.

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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Supportive Care
Official Title: Clinical Protocol for a Randomized Double-Blind, Placebo-Controlled Comparison of the Analgesic Activity of Valdecoxib (SC-65872) 40mg BID as Add-On Therapy to Opioid Medication in Patients With Chronic Cancer Pain
Study Start Date : January 2001
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
Drug Information available for: Valdecoxib
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00021996

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Study Chair: Susana Campos, MD, MPH Dana-Farber Cancer Institute Identifier: NCT00021996     History of Changes
Other Study ID Numbers: DFCI-N91-00-02-040
CDR0000068670 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: February 27, 2004    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: February 2002

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents