Acute Pain Caused by Paclitaxel in Patients With Cancer

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Chemotherapeutic Agent Toxicity; Unspecified Adult Solid Tumor, Protocol Specific; Pain; Neurotoxicity

Treatments: Behavioral: pain questionnaires

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00860041

CDR0000631962 (Registry Identifier)

NCCTG-N08C1

NCI-2009-01108 (Registry Identifier)

Details and patient eligibility

About

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 clinical trial is studying acute pain caused by paclitaxel in patients with cancer.

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

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).

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

Enrollment: 306 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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/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

Trial design

306 participants in 4 patient groups

Group I

Description:

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.

Treatment:

Behavioral: pain questionnaires

Group II

Description:

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.

Treatment:

Behavioral: pain questionnaires

Group III

Description:

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.

Treatment:

Behavioral: pain questionnaires

Group IV

Description:

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.

Treatment:

Behavioral: pain questionnaires