Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Valdecoxib in Treating Chronic Pain in Cancer Patients

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Supportive care	Completed	Legal age and over	Pharmaceutical / Industry	DFCI-N91-00-02-040 BWH-2000-P-000984/7, SC-N91-00-02-040, NCT00021996

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.

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

Expected Enrollment

A maximum of 260 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Susana Campos, MD, MPH, Protocol chair		Ph: 617-632-5874; 866-790-4500

Registry Information
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
Trial Start Date		2001-01-12
Registered in ClinicalTrials.gov		NCT00021996
Date Submitted to PDQ		2001-04-16
Information Last Verified		2002-02-01
NCI Grant/Contract Number		CA06516

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