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Monoclonal Antibodies

Chemotherapy Combinations for Endometrial Cancer

Phase 2

Waitlist Available

Led By Carol Aghajanian

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fasting triglycerides =< 2.5 x ULN (CTCAE v3.0 grade 1)

Histologic confirmation of the original primary tumor is required; eligible histologic epithelial cell types include endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma

Must not have

Prior chemotherapy for abdominal or pelvic tumor within the last three years

History or evidence of central nervous system (CNS) disease exclusion criteria specified

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from date of study entry to time of death or the date of last contact, assessed up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing three different combination chemotherapy regimens to treat endometrial cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include allergic reactions to the drugs used, increased risk of infection due to lowered blood cell counts, potential bleeding issues related to Bevacizumab use, nerve damage that could cause pain or numbness (neuropathy), as well as general symptoms like fatigue and digestive problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My fasting triglyceride levels are within normal limits.

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My cancer is confirmed and is one of the specified types like endometrioid or serous adenocarcinoma.

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I can take care of myself but might not be able to do heavy physical work.

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My kidney function, measured by creatinine, is within the normal range.

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My fasting cholesterol is below 300 mg/dL.

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My endometrial cancer is at a late stage or has come back.

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My white blood cell count is healthy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have a history of brain or spinal cord diseases.

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I do not have any non-healing wounds, ulcers, or bone fractures.

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I do not have lung inflammation, low oxygen levels, or difficulty breathing.

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I have had radiation therapy to my abdomen or pelvis in the last 3 years.

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I do not have any current bleeding or conditions that increase my risk of bleeding.

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I do not have any major heart conditions.

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My diabetes is not under control and my HgbA1C level is above 8.

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I do not have severe numbness or pain in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from date of study entry to time of death or the date of last contact, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from date of study entry to time of death or the date of last contact, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from date of study entry to time of death or the date of last contact, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Who Progressed or Died by 25 Months From Enrollment

Secondary study objectives

The Median Duration of Overall Survival for Each of the Three Arms.

The Proportion of Patients With Measurable Disease Who Have Confirmed Objective Tumor Responses by Treatment.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm III (ixabepilone, carboplatin, bevacizumab)Experimental Treatment4 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 Treatment4 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 Treatment4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Carboplatin

2014

Completed Phase 3

~6120