Chemotherapy + IMPT for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Pranshu Mohindra, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Maryland, Baltimore

Must be taking: Chemotherapy

Disqualifiers: Leiomyosarcoma, Recurrent cancer, Prior RT, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

A phase 2 study with the primary objective of testing treatment compliance of Upfront Intensity Modulated Proton Beam Therapy (IMPT) and Concurrent Chemotherapy (UPPROACH) for Post-operative Treatment in Loco-regionally Advanced Endometrial Cancer is non-inferior to the historic compliance rate of the chemoradiation arm of GOG 258 study

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for endometrial cancer?

Research shows that the combination of carboplatin and paclitaxel is effective in reducing tumor size in patients with advanced or recurrent endometrial cancer, with a significant number of patients experiencing partial responses. This combination is considered a standard initial therapy for advanced endometrial cancer, demonstrating activity against tumors with acceptable levels of side effects. ^{1 2 3 4 5}

Is the combination of chemotherapy drugs Carboplatin and Paclitaxel, along with Intensity Modulated Proton Therapy, generally safe for humans?

The combination of Carboplatin and Paclitaxel has been studied for endometrial cancer and is generally considered to have acceptable levels of toxicity, though some patients experienced significant side effects like hematologic toxicity (blood-related side effects) and neuropathy (nerve damage). Intensity Modulated Proton Therapy has been evaluated in combination with these drugs for cervical cancer, focusing on determining safe dosage levels. ^{1 2 3 4 6}

How does the treatment of Chemotherapy + IMPT for Endometrial Cancer differ from other treatments?

This treatment is unique because it combines chemotherapy drugs, carboplatin and paclitaxel, with Intensity Modulated Proton Therapy (IMPT), a type of radiation therapy that uses protons to precisely target tumors, potentially reducing damage to surrounding healthy tissues compared to traditional radiation. ^{1 2 7 8 9}

Eligibility Criteria

This trial is for adults with advanced endometrial cancer who've had a hysterectomy and possibly other related surgeries. It's open to those with certain stages of cancer, including stage IVA or IA-III if it's clear cell, serous papillary carcinoma, or carcinosarcoma. Participants need normal organ function and no history of heart issues in the past 3 months. They can't have had prior chemotherapy for any cancer.

Inclusion Criteria

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

I am stage IVA and advised to get pelvic radiation and chemotherapy.

Absolute neutrophil count (ANC) ≥ 1000/mcl

Exclusion Criteria

I have recurrent endometrial cancer needing high dose radiotherapy or have had chemotherapy before.

I have significant nodal disease in my pelvis or para-aortic area that wasn't removed and needs a higher radiation dose.

I have not had radiation in the pelvic/abdominal area or chemotherapy that would interfere with this treatment.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Concurrent Chemoradiation

Participants receive concurrent carboplatin and paclitaxel chemotherapy with Intensity Modulated Proton Therapy (IMPT)

5-6 weeks

Weekly visits during radiation treatment

Chemotherapy

Participants complete full 6 cycles of chemotherapy with carboplatin and paclitaxel

18 weeks

Once every 21 days

Follow-up

Participants are monitored for late GI and urinary toxicity

6 months

Treatment Details

Interventions

• Carboplatin and Paclitaxel (Chemotherapy)
• Pelvic IMPT (Intensity Modulated Proton Therapy) (Proton Beam Therapy)

Trial Overview The UPPROACH study tests whether combining Intensity Modulated Proton Beam Therapy (IMPT) with chemotherapy (carboplatin and paclitaxel) after surgery is as good at keeping patients on treatment as previous methods were. This phase 2 trial focuses on compliance rates compared to historical data from the GOG 258 study.

Participant Groups

Group I: Concurrent chemoradiation Experimental Treatment 2 Interventions

Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy)

Carboplatin and Paclitaxel is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Carboplatin and Paclitaxel for:

• Lung cancer
• Ovarian cancer
• Womb cancer
• Cervical cancer

🇺🇸 Approved in United States as Carboplatin and Paclitaxel for:

• Non-small cell lung cancer
• Ovarian cancer
• Cervical cancer
• Endometrial cancer
• Thymoma or thymic carcinoma

🇨🇦 Approved in Canada as Carboplatin and Paclitaxel for:

• Non-small cell lung cancer
• Ovarian cancer
• Breast cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UMMC Baltimore, MD

Baltimore Washington Medical Center Glen Burnie, MD

Maryland Proton Treatment Center Baltimore, MD

Central Maryland Radiation Oncology Columbia, MD

Who Is Running the Clinical Trial?

University of Maryland, Baltimore Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

A phase II study of frontline paclitaxel/carboplatin/bevacizumab, paclitaxel/carboplatin/temsirolimus, or ixabepilone/carboplatin/bevacizumab in advanced/recurrent endometrial cancer. [2023] Paclitaxel and carboplatin (PC) is a standard initial therapy for advanced endometrial cancer. We evaluated the efficacy and tolerability of incorporating three novel agents into initial therapy.

2. United States pubmed.ncbi.nlm.nih.gov

A trial of outpatient paclitaxel and carboplatin for advanced, recurrent, and histologic high-risk endometrial carcinoma: preliminary report. [2016] The purpose of this study was to evaluate the combination of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and carboplatin in patients with endometrial cancer known to be resistant to standard therapy. Subjects were taken from three groups: (1) recurrent or persistent disease following surgery and/or radiation, (2) advanced disease at diagnosis, and (3) high-risk histology. The combination of carboplatin (pharmacologically dosed at an area under the concentration-time curve of 5) and paclitaxel (135 to 175 mg/m2 over 3 hours) was given intravenously every 4 weeks for eight courses. Data about response, overall and progression-free survival, and toxicity were collected. Response and toxicity were evaluated by physical examinations, x-ray films, and blood tests. Twenty patients have participated to date, including eight considered evaluable for response. Due to limited follow-up, survival and progression-free intervals are not yet assessable. Of patients with measurable disease, five of eight (63%) have had significant reduction in the size of evaluable tumor masses, constituting a partial response. Although two patients had clinical and radiographic complete responses, occult disease was found at surgery. There were no complete responders. Fifteen patients had grade 3 or 4 hematologic toxicity, but none had neutropenic fever or hospitalization for sepsis. One patient was taken off study for grade 3 neuropathy. There was one possible treatment-related death. In this preliminary report, this combination is active against tumors of the endometrium, with acceptable levels of toxicity. Further follow-up will be required to determine the duration of response and whether progression-free and overall survival are influenced by treatment with these drugs.

3. United States pubmed.ncbi.nlm.nih.gov

Carboplatin and paclitaxel for the treatment of advanced or recurrent endometrial cancer. [2015] The purpose of this study was to determine the activity and toxicity of carboplatin and paclitaxel (taxol) in the treatment of advanced or recurrent endometrial cancer.

4. United States pubmed.ncbi.nlm.nih.gov

Treatment with paclitaxel plus carboplatin, alone or with irradiation, of advanced or recurrent endometrial carcinoma. [2015] The goal of this study was to evaluate the efficacy and toxicity of paclitaxel plus carboplatin in the treatment of primarily advanced or recurrent endometrial carcinoma.

5. United States pubmed.ncbi.nlm.nih.gov

Dose dense carboplatin paclitaxel improves progression free survival in patients with endometrial cancer. [2022] Pilot study to assess the value of weekly paclitaxel plus carboplatin every 3weeks (dose dense regimen, DD) compared to the standard 3-weekly protocol in the adjuvant setting for endometrial cancer.

6. England pubmed.ncbi.nlm.nih.gov

A phase I study of concurrent weekly carboplatin and paclitaxel combined with intensity-modulated pelvic radiotherapy as an adjuvant treatment for early-stage cervical cancer patients with positive pelvic lymph nodes. [2020] The objective of this study was to determine the maximum tolerated dose (MTD) and acute dose-limiting toxicities (DLTs) of intravenous carboplatin plus paclitaxel combined with intensity-modulated pelvic radiotherapy (pelvic IMRT) as an adjuvant treatment for early-stage cervical cancer patients with positive pelvic lymph nodes.

7. United States pubmed.ncbi.nlm.nih.gov

Paclitaxel, topotecan, and carboplatin in metastatic endometrial cancinoma: a Hellenic Co-operative Oncology Group (HeCOG) study. [2015] Taxanes, and platinum compounds represent the chemotherapeutic agents with the greatest activity in metastatic endometrial carcinoma. We administered the combination of paclitaxel, topotecan and carboplatin to patients with metastatic or recurrent carcinoma of the endometrium to evaluate its activity and to define its toxicity.

8. England pubmed.ncbi.nlm.nih.gov

Prolonged remission of endometrial cancer with paclitaxel and carboplatin. [2019] Recurrent endometrial cancer has grave prognosis. Chemotherapy and hormonal therapy are mainstays of palliative treatment. Unfortunately the frequency of complete response and duration of progression-free interval are limited. This case report describes a patient with recurrent metastatic endometrial cancer who was initially treated with radiotherapy followed by surgery. Her recurrent tumor progressed during treatment with external radiation and a progestogen. She received paclitaxel (135 mg/m2 i.v. infusion over 24 h) and carboplatin (AUC 7.5 microg x h/ml) every 4 weeks with complete remission after 8 months which has persisted for 22 months. Paclitaxel and carboplatin combination should be considered for the treatment of endometrial cancer.

9. United States pubmed.ncbi.nlm.nih.gov

A feasibility study of carboplatin and weekly paclitaxel combination chemotherapy in endometrial cancer: a Kansai Clinical Oncology Group study (KCOG0015 trial). [2015] The optimal chemotherapy regimen for women with endometrial cancer has not been established. We assessed the feasibility, toxicity and clinical efficacy of combination triweekly carboplatin and weekly paclitaxel in women with endometrial cancer.