Uterine Serous Carcinoma and Adjuvant Combined Intraperitoneal Chemotherapy and Radiation

NCT04030000 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: USC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Uterine serous carcinoma (USC) is an uncommon, but aggressive variant of endometrial carcinoma that has poor response to standard therapy. After staging and surgery, radiation therapy and/or chemotherapy is recommended to treat patients at high risk for recurrence. In advanced stage and recurrent setting, high risk uterine cancer mirrors ovarian cancer with it spread patterns and response to therapy. Based on these findings and the similarities as well as the clinical success of paclitaxel with IP platinum therapy in patients with ovarian serous carcinoma, investigators propose to prospectively assess IV/IP therapy in patients with advanced stage and recurrent USC. During Week 1-18, subjects will be placed on open-label IP Carboplatin/IV Paclitaxel on Day 1, then administered IP Paclitaxel on Day 8. This will be repeated every 3 weeks for 6 cycles. A CT imaging scan will be performed after six cycles of chemotherapy, prior to radiation. Also, in Week 19-23, subjects will receive Pelvic radiation therapy (IMRT) if deemed necessary. Additionally, from Week 24-26, High Dose Radiation or IMRT will be used where appropriate. Patients will be monitored for toxicity and feasibility of the regimen. Secondary outcomes will include assessing the frequency and the reasons for early discontinuation of the study treatments as well as describing patient-reported quality of life parameters at specified time points during the study using validated questionnaires: EORTC QLQ-C30 and QLQ-OV28.

Conditions

Uterine Carcinoma

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-related Adverse Events

  Number of patients with treatment-related adverse events as assessed by CTCAE v4.0

  2 years post diagnosis

• Feasibility of above regimen in women with advanced stage USC

  Feasibility will be assessed by: Treatment completion proportion - the proportion of participants who complete the IV paclitaxel/IP carboplatin followed by IP paclitaxel/RT regimen Screening ratio - the number of potential participants screened per enrolled participant

  2 years post diagnosis

Secondary Outcomes (1)

• Patient quality of life

  Baseline (after surgery, prior to initiating first cycle), Completion of chemotherapy (18 weeks after Cycle 1 Day 1),Completion of radiation therapy (26 weeks after Cycle 1 Day), Two years post diagnosis

Study Arms (1)

Paclitaxel/Carboplatin and radiation

OTHER

Paclitaxel 135 mg/m2 over 3 hrs on day 1 Carboplatin IP (AUC= 6.0) on day 1 Paclitaxel 60 mg/m2 IP on Day 8 Repeat q 21 days x 6 cycles Pelvic 6MV Photon Beam Energy, or IMRT where appropriate 1.8 Gy Dose/FX Total Dose 45 Gy High Dose Radiation (HDR) x 3, or IMRT where appropriate 5 Gy to 0.5cm Depth from the Vaginal Cylinder Surface Total Dose 15 Gy

Drug: Paclitaxel/Carboplatin; Radiation: Pelvic radiation therapy

Interventions

Paclitaxel/Carboplatin DRUG

IV paclitaxel in combination with IP carboplatin

Paclitaxel/Carboplatin and radiation

Pelvic radiation therapy RADIATION

EBRT and vaginal brachytherapy

Paclitaxel/Carboplatin and radiation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological/cytologically documented primary FIGO Stage IIIA, IIIB, IIIC1, IIIC2, IVA and IVB uterine serous carcinoma. Patients with stage IVB disease include abdominal sites of metastasis only.
• All patients must have a procedure for determining the definitive diagnosis of USC. At the discretion of the surgeon, complete surgical staging should include: total hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, omental biopsy and lymph node evaluation.
• Residual disease at completion of surgery of ≤ 1cm by surgeon report.
• Age \> 18 years.
• ECOG performance status of ≤ 2.
• Written voluntary informed consent.

You may not qualify if:

• Distant metastasis outside the abdominal cavity.
• Patient has impairment of hepatic, renal or hematologic function as defined by the following baseline laboratory values:
• Serum SGOT and /or SGPT \> 2.5 times the institutional upper limit of normal (ULN)
• Total serum bilirubin \> 1.5 mg/dl
• Serum creatinine \> 2.0 mg/dl
• Platelets \< 100,000/mm3
• Absolute neutrophil count (ANC) \< 1500/mm3
• Hemoglobin \< 8.0 g/dl (the patient may be transfused prior to study entry)
• History of abdominal/pelvic radiation therapy.
• Severe or uncontrolled, concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
• Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Arisa Kapedani

New Hyde Park, New York, 11040, United States

Location

Related Publications (30)

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MeSH Terms

Interventions

CP protocol

Study Officials

• Karin Shih, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: During Week 1-18, subjects will be placed on open-label IP Carboplatin/IV Paclitaxel on Day 1, then administered IP Paclitaxel on Day 8. This will be repeated every 3 weeks for 6 cycles. A CT imaging scan will be performed after six cycles of chemotherapy, prior to radiation. Also, in Week 19-23, subjects will receive Pelvic radiation therapy (IMRT) if deemed necessary. Additionally, from Week 24-26, High Dose Radiation or IMRT will be used where appropriate.

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: July 23, 2019
• Study Start: May 20, 2020
• Primary Completion: August 30, 2022
• Study Completion: January 30, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)