20 Participants Needed

Paclitaxel Monitoring for Cancer

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Overseen ByAshley Fansler, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
Must be taking: Paclitaxel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a method to measure the chemotherapy drug paclitaxel in the blood of cancer patients. Paclitaxel stops cancer cells from growing but can also cause nerve damage. By monitoring paclitaxel levels in the blood, doctors may adjust doses to kill cancer cells while reducing nerve problems. The trial seeks patients with solid tumors, such as breast, lung, or ovarian cancer, who plan to receive paclitaxel as part of their treatment. Patients without prior nerve issues or certain types of chemotherapy may be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with your doctor to understand how your current medications might interact with the trial treatment.

What prior data suggests that paclitaxel is safe for cancer patients?

Research has shown that paclitaxel, a common chemotherapy drug, can be challenging for some patients due to its side effects. Nerve damage, one of the most serious side effects, can cause pain or numbness, often in the hands and feet. Some studies have found that long-term use of paclitaxel can also harm critical areas, such as the central nervous system and bone marrow. Additionally, paclitaxel may cause skin irritation and allergic reactions in some individuals.

Despite these potential side effects, doctors have long used paclitaxel to treat cancer. It is well-known for its ability to target and kill cancer cells, maintaining its popularity. While side effects are a concern, ongoing research seeks better management strategies. By monitoring paclitaxel levels in the blood, doctors aim to adjust doses and reduce the risk of nerve damage.12345

Why are researchers excited about this trial?

Researchers are excited about paclitaxel therapeutic drug monitoring because it offers a personalized approach to cancer treatment. Unlike traditional methods where a standard dose is given to all patients, this monitoring allows doctors to tailor the dose specifically to an individual's needs, potentially increasing effectiveness and reducing side effects. This personalized dosing method aims to optimize the therapeutic outcomes for each patient, which could make a significant difference in how cancer is managed.

What is the effectiveness track record for paclitaxel in treating solid tumors?

Studies have shown that paclitaxel effectively treats various types of cancer by stopping cancer cells from growing and spreading. Research has indicated that nab-paclitaxel, a form of paclitaxel, helps patients with advanced breast and lung cancer live longer and respond better to treatment. However, nerve damage commonly occurs as a side effect. By monitoring paclitaxel levels in the blood, doctors can adjust the dose to enhance its effectiveness against cancer while reducing the risk of nerve damage.678910

Who Is on the Research Team?

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Roy Strowd, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

Inclusion Criteria

Male or female sex
Invasive breast cancer (any HER2 and ER/PR status)
Patients considered for curative or palliative chemotherapy with paclitaxel 80-175 mg/m2 with or without doxorubicin, cyclophosphamide, carboplatin, trastuzumab, bevacizumab, or pertuzumab
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Paclitaxel treatment and undergo therapeutic drug monitoring

Varies based on individual treatment plans

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of neuropathy and inflammasome activation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Paclitaxel

Paclitaxel is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Taxol for:
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Approved in European Union as Taxol for:
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Approved in Canada as Paclitaxel for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

A Real-World Efficacy of Nab-Paclitaxel Monotherapy in ...

This real-world data shows that nab-paclitaxel is a reasonable treatment option in heavily pre-treated and/or taxane-exposed metastatic breast cancer patients.

Efficacy and safety of nanoparticle albumin-bound ...

Nab-paclitaxel enhances OR, PR, PFS, and marginally improves OS in advanced NSCLC, particularly in patients with prior chemotherapy.

Real-world study on the effect of nab-paclitaxel treatment ...

Nab-paclitaxel showed manageable tolerability and favorable response rates in metastatic cancer patients. It is widely used beyond approved indications.

Efficacy and safety of nanoparticle-albumin-bound ...

Nab-paclitaxel also showed significantly longer OS (HR 0.73, 95% CI 0.54–0.99, p = 0.04) than docetaxel. AEs and DDR were comparable between the ...

Nab-Paclitaxel: A New Standard of Care in Neoadjuvant ...

The primary end point of overall response rate was improved with nab-paclitaxel (33% v 19%), as was median time to tumor progression (23 v 16.9 ...

Abraxane Safety Data Sheet

This substance is classified as hazardous under GHS as implemented by. Regulation EC No 1272/2008 (EU CLP), WHMIS 2015 (Health Canada), and. Hazard ...

SAFETY DATA SHEET

H372. Causes damage to organs (Central nervous system, Bone marrow, Cardio-vascular system) through prolonged or repeated exposure.

MATERIAL SAFETY DATA SHEET

Additional Hazard Information: Long Term: Repeat-dose studies in animals have shown a potential to cause adverse effects on blood and blood forming organs.

Paclitaxel Protein

P310 - Immediately call a poison center or doctor. P321 - Specific treatment (see section 4 on this SDS). P333+P313 - If skin irritation or rash ...

Safety Data Sheet

Trade name: Paclitaxel​​ Skin irritation 2 H315 Causes skin irritation. Sensitization - skin 1 H317 May cause an allergic skin reaction.