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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two chemotherapy drugs, carboplatin and paclitaxel, along with radiotherapy to determine its safety for treating locally advanced endometrial cancer. Researchers aim to discover if this treatment causes serious side effects. The trial seeks women who have undergone surgery for certain types of endometrial cancer and require additional treatment. Women who have had a hysterectomy and have endometrial cancer with specific high-risk features may qualify for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important advancements in cancer care.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are on other investigational drugs or have had certain treatments like prior platinum or taxane-based chemotherapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that patients generally tolerate the combination of carboplatin and paclitaxel well. Studies have found that this treatment is often used for ovarian cancer and typically does not require additional growth factors to aid blood cell production. Most patients can undergo the treatment without serious issues.

Other studies have safely used this combination in individuals with advanced endometrial cancer. While some side effects may occur, they are often manageable. These findings offer strong evidence of the treatment's safety, particularly since it is already a common choice for other cancer types. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for endometrial cancer?

Researchers are excited about the combination of CarboTaxol and radiotherapy for endometrial cancer because it offers a unique approach compared to standard treatments like surgery, radiation, or chemotherapy alone. This regimen strategically combines full-dose and reduced-dose cycles of carboplatin and paclitaxel with pelvic radiotherapy, aiming to enhance effectiveness while potentially minimizing side effects. By alternating the intensity of chemotherapy and integrating targeted radiotherapy, this treatment plan might improve patient outcomes in a way that traditional treatments do not.

What evidence suggests that this trial's treatments could be effective for endometrial cancer?

Research has shown that using carboplatin and paclitaxel with radiotherapy can effectively treat advanced endometrial cancer. In this trial, participants will receive a regimen of full-dose carboplatin and paclitaxel, followed by reduced-dose carboplatin and paclitaxel with radiotherapy, and then return to full-dose chemotherapy. One study found that this combination helps patients with advanced or recurring endometrial cancer live longer. Another study confirmed that using these drugs followed by radiotherapy is safe and effective for patients at high risk. The treatment also has low rates of serious side effects, making it a promising option. Overall, these findings support using carboplatin and paclitaxel with radiotherapy to manage endometrial cancer. ^{1 3 4 6 7}

Who Is on the Research Team?

Matthew Harkenrider, MD

Principal Investigator

Loyola University Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7676887/

Carboplatin and Paclitaxel for Advanced Endometrial Cancer This was the first trial to show a survival advantage for combination chemotherapy in patients with measurable advanced or recurrent endometrial cancer. For ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825824010461

A phase 2 feasibility study of nab-paclitaxel and ... Dose-dense nab-paclitaxel on day 1, 8 with day 1 carboplatin every 3 weeks is feasible (6-cycle completion rate of 82.6%).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00584909

A Phase II Study of Paclitaxel and Carboplatin in Patients ... The safety of this combination is well established in a number of phase III trials and currently is used in the primary setting for patients with ovarian cancer ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10373231/

Looking Beyond Carboplatin and Paclitaxel for the ... Median OS was 37 months and 41 months, respectively (HR: 1.002; 90% CI: 0.9 to 1.12); median progression-free survival (PFS) was 13 months and 14 months, ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT183754

Adjuvant carboplatin and paclitaxel chemotherapy followed ... Conclusions: Our data suggests that adjuvant carboplatin and paclitaxel, followed by RT, in high-risk endometrial cancer is safe and effective. Low rates of ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)00721-X/fulltext

Overall survival in patients with endometrial cancer treated ... An improvement of 13.9 months in median PFS2 was observed in patients receiving dostarlimab plus carboplatin–paclitaxel (median PFS2 of 32.3 ...

7. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-023-11654-z

PD-1/PD-L1 inhibitors plus carboplatin and paclitaxel ... Immunotherapy plus carboplatin-paclitaxel increased significantly PFS and OS among patients with advanced or recurrent endometrial cancer.