Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients with Cancer
18 Years and older, Male and Female
S1714 (primary)
S1714
SWOG-S1714
NCI-2018-01568
Summary
This trial studies treatment effects on development of chemotherapy-induced peripheral neuropathy in patients with cancer. Treatments for cancer can cause a problem to the nervous system (called peripheral neuropathy) that can lead to tingling or less feeling in hands and feet. Studying certain risk factors, such as age, gender, pre-existing conditions, and the type of treatment for cancer may help doctors estimate how likely patients are to develop the nerve disorder.
Objectives
PRIMARY OBJECTIVE:
I. To develop and validate a clinical risk prediction model using clinical factors for the development of peripheral neuropathy in patients receiving taxane-based chemotherapy regimens.
SECONDARY OBJECTIVES:
I. To examine patient-reported outcomes (PROs) and objective measures of chemotherapy induced peripheral neuropathy (CIPN) to better define the phenotype of peripheral neuropathy in this patient population.
II. To assess the incidence of CIPN within one year in this patient population.
III. To identify predictors of treatment dose reductions, delays, and discontinuations associated with CIPN symptoms in this patient population.
OTHER OBJECTIVE:
I. To collect serum and plasma samples for future testing for biomarker and mechanistic studies of CIPN.
OUTLINE:
Patients receive chemotherapy regimen per treating physician for 156 weeks (3 years) in the absence of disease progression or unacceptable toxicity. Patients also complete questionnaires and undergo blood sample collection at baseline and while on study.
Eligibility
- Patients must have stage I, II, or III primary non-small cell lung, primary breast, or primary ovarian/fallopian tube/peritoneal cancer based on clinical or pathologic evaluation. Patients with stage IV disease are not eligible.
- Patients must be planning to start treatment with a taxane-based chemotherapy as part of one of the study-approved taxane regimens (docetaxel chemotherapy regimens for treatment of breast or ovarian/fallopian tube/peritoneal cancer, or paclitaxel chemotherapy regimens for treatment of breast, non-small cell lung, or ovarian/fallopian tube/peritoneal cancer) within 14 days after registration. (Note that carboplatin is allowed. However any of the regimens may be combined with a non-neurotoxic chemotherapy, such as cyclophosphamide, and/or a biologic agent, such as trastuzumab. Permitted biologic agents include, but are not limited to, pembrolizumab, bevacizumab, trastuzumab, and/or pertuzumab. Nab-paclitaxel may not be substituted for paclitaxel for purposes of this study.)
- Patients who will receive treatment in the setting of any other clinical trial are eligible as long as it is one of the study-approved regimens. Patients may receive additional treatments (i.e., experimental therapy, immunotherapy, biologics, etc.) as part of another clinical trial in addition to any regimen approved in this study.
- Patients must not have received a taxane (paclitaxel, docetaxel, or protein-bound paclitaxel), platinum (cisplatin, carboplatin, or oxaliplatin), vinca alkaloid (vinblastine, vincristine, or vinorelbine), or bortezomib-based chemotherapy regimen prior to registration. (Note that while patients must not have received carboplatin in the past, patients may receive a carboplatin-containing regimen after registration as part of the docetaxel or paclitaxel regimen.)
- Patients must be >= 18 years of age
- Patients must be able to complete Patient-Reported Outcome (PRO) instruments in English or Spanish. Patients must:
* Agree to complete PROs at all scheduled assessments.
* Complete the baseline PRO forms prior to registration.
- Patients with pre-existing neuropathy are eligible, including those with diabetes and neurological conditions such as multiple sclerosis or Parkinson’s disease.
- Patients must agree to submit required specimens for defined translational medicine.
- Patients must be offered the opportunity to submit additional optional specimens for future, unspecified translational medicine and banking. With patient’s consent, specimens must be submitted.
- Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.
- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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