CarboTaxol + Radiotherapy for Endometrial Cancer

Overseen By Beth Chiappetta, BSN

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Loyola University

Must not be taking: Investigational agents

Disqualifiers: Prior radiotherapy, Prior chemotherapy, Others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

24 Participants Needed

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.

Research Team

Matthew Harkenrider, MD

Principal Investigator

Loyola University Chicago

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sequential and concurrent carboplatin and paclitaxel with adjuvant external beam radiotherapy

16 weeks

Multiple visits for chemotherapy and radiotherapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Treatment Details

Interventions

• Carboplatin
• External Beam Radiotherapy
• Paclitaxel

Trial Overview 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.

Participant Groups

Group I: Full Dose Chemo, Reduced Dose Chemo + RT, Full Dose Chemo Experimental Treatment 2 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:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Loyola University

Lead Sponsor

Trials

161

Recruited

31,400+