CarboTaxol + Radiotherapy for Endometrial Cancer

Palo Alto (17 mi)

Overseen byMatthew Harkenrider, MD

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Loyola University

Stay on your current meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this trial is to evaluate the safety of sequential and concurrent carboplatin and paclitaxel with adjuvant external beam radiotherapy for locally advanced endometrial cancer. The primary objective is to assess the acute toxicities namely grade 3-4 non hematologic and grade 4 hematologic toxicities associated with the above regimen. The null hypothesis is that the unacceptable toxic response rate is ≥40%. This will be tested against a one-sided alternative that the toxicity rate is 20% or less. Simon's two-stage design was used to power this aim. In the first stage, 11 patients will be accrued. If there are 5 or more toxic responses in these 11 patients, the study will be stopped for safety reasons. Otherwise, 13 additional patients will be accrued for a total of 24 patients. Under these conditions, the probability of stopping early is 47% if the toxic response rate is truly higher than 20.0%. If this regimen is safe then its efficacy can be studied in a Phase III study.

Eligibility Criteria

This trial is for individuals with high-risk endometrial cancer who've had surgery. It's open to those with certain types of cancer cells, recommended for combined chemo and radiotherapy post-surgery, without prior pelvic radiation or evidence of spread beyond the pelvis. Participants must be able to perform daily activities with little to no assistance (ECOG 0-2) and give informed consent.

Inclusion Criteria

I can care for myself and am up and about more than 50% of my waking hours.

My cancer is in stages I to IV and is one of the specified types.

I have never had radiation therapy to my pelvic area.

My doctor recommends both chemotherapy and radiation after reviewing my cancer.

My cancer has not spread to lymph nodes or other parts of my body.

I had surgery for endometrial cancer with a specific type of tumor.

My endometrial cancer is at an early or specific advanced stage with high risk features.

Treatment Details

The trial tests how safe it is to use Carboplatin and Paclitaxel chemotherapy in sequence or at the same time as external beam radiotherapy after surgery. The main focus is on severe side effects from this treatment combination. Initially, 11 patients will be tested; if too many experience serious side effects, the study may stop early.

1Treatment groups

Experimental Treatment

Group I: Full Dose Chemo, Reduced Dose Chemo + RT, Full Dose ChemoExperimental Treatment2 Interventions

Week 1 : Cycle 1: Full Dose Carboplatin and Paclitaxel Week 4: Pelvic Radiotherapy Begins Cycle 2: Dose reduced Carboplatin and Paclitaxel Week 7 : Cycle 3: Dose reduced Carboplatin and Paclitaxel Weeks 10,13,16: Cycle 4-6: Full Dose Carboplatin and Paclitaxel

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

🇺🇸 Approved in United States as Paraplatin for: