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Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

To learn if chemotherapy given in combination with radiation therapy, followed by maintenance therapy, can help to control endometrial cancer. The safety and effects of this study treatment will also be studied

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

∙ Patients are eligible to participate on this study only if they meet all of the following inclusion criteria.

• Has read and understands the informed consent form (ICF) and has given written informed consent prior to any study procedures

• Have surgically staged IIIC, pathologically confirmed endometrial cancer of any histologic subtype and be eligible for adjuvant chemoradiation followed by chemotherapy (Note: Surgical staging is defined as total hysterectomy and lymph node assessment.)

• Enrolled within 8 weeks of surgery and started treatment within 10 weeks of surgery

• Age ≥ 18 years

• Performance Status of ECOG 0 or 1 (see Performance Status Criteria)

• Adequate hematologic function within 14 days prior to enrollment defined as follows:

‣ Hemoglobin ≥ 9 g/dL

⁃ Platelets ≥ 100,000/mcl

⁃ Absolute neutrophil count (ANC) ≥ 1,500/mcl

• Adequate renal function within 14 days prior to enrollment defined as follows: Creatinine

• ≤ 2 x laboratory upper limit of normal (ULN) or CrCl ≥60ml/min

• Adequate hepatic function within 14 days prior to enrollment defined as follows:

‣ Bilirubin ≤ 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level ≤ 2 x ULN may be enrolled)

⁃ ALT and AST ≤ 2.5 x ULN

• Adequate coagulation within 14 days prior to enrollment defined as INR or PT/aPTT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.

⁃ Prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial (i.e. non-melanomatous skin cancer).

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Pamela Soliman, MD
psoliman@mdanderson.org
713-745-2352
Time Frame
Start Date: 2023-07-17
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 21
Treatments
Experimental: Adjuvant Therapy During Radiation
Participants will receive an active treatment for 6 cycles. Participants will be on maintenance for 14 cycles, as long as the disease does not get worse. Follow-up will then occur every 6 months for 5 years (from your enrollment date).
Experimental: Adjuvant Therapy After Radiation
Participants will receive an active treatment for 6 cycles. Participants will be on maintenance for 14 cycles, as long as the disease does not get worse. Follow-up will then occur every 6 months for 5 years (from your enrollment date).
Experimental: Immunotherapy after Radiation and Chemo
Participants will receive an active treatment for 6 cycles. Participants will be on maintenance for 14 cycles, as long as the disease does not get worse. Follow-up will then occur every 6 months for 5 years (from your enrollment date).
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

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