Chemotherapy Combinations for Endometrial Cancer

Recruiting at262 trial locations

Overseen by Carol Aghajanian

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies paclitaxel, carboplatin, and bevacizumab or paclitaxel, carboplatin, and temsirolimus or ixabepilone, carboplatin, and bevacizumab to see how well they work in treating patients with stage III, stage IV, or recurrent endometrial cancer. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known which treatment regimen is most effective in treating patients with endometrial cancer.

Research Team

Carol Aghajanian

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for adults with advanced (stage III/IV) or recurrent endometrial cancer. Eligible participants may have had hormonal therapy but must not have received chemotherapy, targeted therapy, or radiation outside of specific criteria. They should have a certain level of blood cells and organ function, no serious wounds or bleeding risks, controlled seizures if present, stable heart conditions without recent severe events, and no known allergies to certain biologic drugs.

Inclusion Criteria

Informed consent and authorization required

Bilirubin <= 1.5 x ULN (CTCAE v3.0 grade 1)

SGOT and SGPT <= 2.5 x ULN (CTCAE v3.0 grade 1)

Exclusion Criteria

Known hypersensitivity to specific products exclusion criteria specified

Pregnant or nursing exclusion criteria specified

I have had chemotherapy for a tumor in my abdomen or pelvis in the last 3 years.

Treatment Details

Interventions

• Bevacizumab (Monoclonal Antibodies)
• Carboplatin (Alkylating agents)
• Ixabepilone (Other)
• Paclitaxel (Anti-tumor antibiotic)
• Temsirolimus (mTOR Inhibitor)

Trial Overview The study compares three treatment combinations: Paclitaxel with Carboplatin and Bevacizumab; Paclitaxel with Carboplatin and Temsirolimus; Ixabepilone with Carboplatin and Bevacizumab. It aims to find out which regimen is most effective in stopping tumor growth by killing the cells or preventing them from dividing.

Participant Groups

Group I: Arm III (ixabepilone, carboplatin, bevacizumab) Experimental Treatment 4 Interventions

Patients receive ixabepilone IV over 1 hour, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (paclitaxel, carboplatin, temsirolimus) Experimental Treatment 4 Interventions

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and temsirolimus IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Group III: Arm I (paclitaxel, carboplatin, bevacizumab) Experimental Treatment 4 Interventions

Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Bevacizumab is already approved in Japan, Canada for the following indications:

Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School