Status:
COMPLETED
Acute Pain Caused by Paclitaxel in Patients With Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chemotherapeutic Agent Toxicity
Neurotoxicity
Eligibility:
All Genders
18+ years
Brief Summary
RATIONALE: Gathering information over time from patients receiving paclitaxel for cancer may help doctors learn more about pain caused by paclitaxel and plan the best treatment. PURPOSE: This clinica...
Detailed Description
OBJECTIVES: * To describe the incidence and characteristics of and change in pain related to paclitaxel infusions over several courses in patients receiving paclitaxel weekly or every 2-4 weeks with ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Planning to receive paclitaxel IV (excluding paclitaxel albumin-stabilized nanoparticle formulation \[nab-paclitaxel\]) according to one of the following dosing schedules:
- At least 175 mg/m\^2 at 2-4 week intervals (course duration of 2, 3, or 4 weeks, respectively)
- 70-90 mg/m\^2 weekly (3 out of 4 weeks allowed)
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy \> 6 months
- Able to complete questionnaires (alone or with assistance)
- Willing to provide required biological specimens
- No prior or concurrent peripheral neuropathy (from diabetes or other causes)
- No prior or concurrent fibromyalgia
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior paclitaxel or neurotoxic chemotherapy drugs, including other taxanes, platinum agents, vinca alkaloids, or epothilones
- No concurrent neutrophil colony-stimulating factor therapy
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT00860041
Start Date
February 1 2009
End Date
May 1 2013
Last Update
July 14 2016
Active Locations (279)
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1
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
2
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
3
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
4
St. Anthony Central Hospital
Denver, Colorado, United States, 80204