NCT00021996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2001

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 27, 2004

Completed
Last Updated

July 18, 2013

Status Verified

February 1, 2002

First QC Date

August 10, 2001

Last Update Submit

July 17, 2013

Conditions

PainUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificpain

Interventions

valdecoxibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pain

Interventions

valdecoxib

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Susana Campos, MD, MPH

    Dana-Farber Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2001

First Posted

February 27, 2004

Study Start

January 1, 2001

Study Completion

February 1, 2004

Last Updated

July 18, 2013

Record last verified: 2002-02

Locations

US(2)