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

Alternate Title

Acute Pain Caused by Paclitaxel in Patients With Cancer

Basic Trial Information

Objectives

1. 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 or without neurotoxic chemotherapy.
2. To investigate the association between paclitaxel-induced acute pain syndrome symptoms and eventual chemotherapy-induced neuropathy.
3. To perform exome-sequencing analysis and identify genetic variants that predict paclitaxel- induced peripheral neuropathy.
4. To identify clinical phenotypes associated with paclitaxel toxicity (i.e., acute pain syndrome and neuropathy).
5. To explore whether there are any evident differences between results seen in the majority Caucasian population and the minority populations.

Entry Criteria

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/m² at 2-4 week intervals (course duration of 2, 3, or 4 weeks, respectively)
  • 70-90 mg/m² weekly (3 out of 4 weeks allowed)

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

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

Expected Enrollment

Outcomes

Maximum of the worst pain scores from the initiation of paclitaxel therapy (day 1) until day 7 (first week of therapy)

Maximum of the average pain score
Area under the curve of worst, average, and least pain
Development of new aches/pains attributed to paclitaxel
Worst pain reported for the overall week
Rate of non-prescription pain medication use
Rate of opioid use
Rate of other pain therapy use
Correlation of the worst pain score for the first dose of therapy with subsequent neuropathy scores
Relationship between genetic biomarkers and the worst pain score
Differences between the results seen in the majority Caucasian population and the minority population (as a whole and broken down into Hispanic vs Black vs Asian vs Native American vs Pacific Islander)
Correlation of baseline pain, baseline analgesic intake, or baseline neuropathy symptoms with the eventual development of paclitaxel-associated acute pain syndrome or neuropathy

Outline

This is a multicenter study. Patients are grouped according to paclitaxel dosing schedule (weekly vs every 2-4 weeks) and concurrent use of neurotoxic agent (yes vs no).

• Group I: Patients complete pain questionnaires at baseline, 2-8 days after each weekly paclitaxel treatment given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.

• Group II (closed to accrual as of 12/4/2009): Patients complete pain questionnaires at baseline, 2-8 days after each weekly paclitaxel treatment not given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.

• Group III (closed to accrual for general population, but remains open to minority accrual only as of 8/7/2009): Patients complete pain questionnaires at baseline, 2-8 days after each 2-4 week paclitaxel treatment given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.

• Group IV: Patients complete pain questionnaires at baseline, 2-8 days after each 2-4 week paclitaxel treatment not given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.

Blood samples are collected at baseline for correlative laboratory studies, including genetic biomarker and polymorphism studies.

Reeves BN, Dakhil SR, Sloan JA, et al.: Further data supporting that paclitaxel-associated acute pain syndrome is associated with development of peripheral neuropathy: North Central Cancer Treatment Group trial N08C1. Cancer : , 2012.[PUBMED Abstract]

Loprinzi CL, Reeves BN, Dakhil SR, et al.: Natural history of paclitaxel-associated acute pain syndrome: prospective cohort study NCCTG N08C1. J Clin Oncol 29 (11): 1472-8, 2011.[PUBMED Abstract]

Reeves B, Dakhil SR, Sloan JA, et al.: Paclitaxel-associated acute pain syndrome (P-APS) and its association on the development of peripheral neuropathy: NCCTG trial N08C1. [Abstract] J Clin Oncol 29 (Suppl 15): A-9047, 2011.

Reeves B, Dakhil SR, Sloan JA: Natural history of paclitaxel-associated acute pain syndrome (P-APS): NCCTG trial N08C1. [Abstract] J Clin Oncol 28 (Suppl 15): A-9135, 2010.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Charles Loprinzi, MD, Principal investigator		Ph: 507-284-8964 Email: cloprinzi@mayo.edu

Registry Information
Official Title		Paclitaxel-Associated Acute Pain Syndrome Natural History Study
Trial Start Date		2009-02-27
Trial Completion Date		2011-04-30 (estimated)
Registered in ClinicalTrials.gov		NCT00860041
Date Submitted to PDQ		2009-03-05
Information Last Verified		2012-05-11

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