Paclitaxel and Intraperitoneal Carboplatin Followed by Radiation Therapy in Treating Patients With Stage IIIC-IV Uterine Cancer

NCT02112552 | Terminated Phase 2 Results DMC

• 3 other identifiers: 13-02-058NCI-2013-01226P30CA013330
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot, phase II trial studies the side effects and how well paclitaxel given into the vein and carboplatin given directly into the abdominal cavity (intraperitoneally) followed by radiation therapy work in treating patients with stage IIIC-IV serous uterine cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, stopping them from dividing, or stopping them from spreading. Giving the drugs in different ways may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy followed by radiation therapy may be an effective treatment for uterine cancer.

Conditions

Endometrial Serous Adenocarcinoma; Stage IIIA Uterine Corpus Cancer; Stage IIIB Uterine Corpus Cancer; Stage IIIC1 Uterine Corpus Cancer; Stage IIIC2 Uterine Corpus Cancer; Stage IVA Uterine Corpus Cancer; Stage IVB Uterine Corpus Cancer

Outcome Measures

Primary Outcomes (1)

• Degree of Tolerability, Estimated by the Proportion of Participants Who Complete 6 Treatment Cycles of IP Carboplatin

  At the end of the study, the proportion of patients who tolerated the therapy will be estimated, along with corresponding 95% confidence intervals. Reasons for discontinuation of therapy will be categorized and summarized by computing frequencies.

  Up to 18 weeks

Secondary Outcomes (1)

• Progression-free Survival

  The duration of time from start of treatment to time of progression, or death, whichever happens first, assessed at 1 year

Study Arms (1)

Treatment (paclitaxel, carboplatin, radiotherapy)

EXPERIMENTAL

CHEMOTHERAPY: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IP on day 1. Treatment repeats every 21 days for up to 6 courses (weeks 1-18) in the absence of disease progression or unacceptable toxicity. RADIATION: At provider discretion, patients may undergo 3D conformal or IMRT 5 days a week for 5 weeks (weeks 19-23).

Drug: Paclitaxel; Drug: Carboplatin; Radiation: 3-Dimensional Conformal Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Laboratory Biomarker Analysis

Interventions

Paclitaxel DRUG

Given IV

Also known as: Anzatax, TAX

Treatment (paclitaxel, carboplatin, radiotherapy)

Carboplatin DRUG

Given IP

Treatment (paclitaxel, carboplatin, radiotherapy)

3-Dimensional Conformal Radiation Therapy RADIATION

Undergo 3D conformal radiation therapy

Also known as: 3D-CRT, Conformal Therapy, Radiation Conformal Therapy

Treatment (paclitaxel, carboplatin, radiotherapy)

Intensity-Modulated Radiation Therapy RADIATION

Undergo IMRT

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy

Treatment (paclitaxel, carboplatin, radiotherapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (paclitaxel, carboplatin, radiotherapy)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (paclitaxel, carboplatin, radiotherapy)

Eligibility Criteria

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

You may qualify if:

• Histological/cytologically documented primary International Federation of Gynecology and Obstetrics (FIGO) stage 3C1, 3C2, stage 4A, and 4B uterine serous carcinoma; in addition, certain stage 3A and B disease are also allowed
• Residual disease after primary surgery:
• Eligible:
• Stage 3A and B (pelvic, but confined to adnexa or vagina), residual disease present
• Stage 3CI (pelvic node positive)
• Stage 3CII (para-aortic node positive)
• Stage 4A (bladder or pelvic bowel)
• Stage 4B (distant metastases \[mets\] including abdominal mets), completely resected
• Not eligible
• Stage 3A and B (pelvic, but confined to adnexa or vagina), completely resected
• Stage 4B (distant mets including abdominal mets), residual disease present
• All patients must have a procedure for determining diagnosis of high-risk uterine cancer (HRUC); minimum surgical intervention required is tissue biopsy (may be from endometrium), if significant clinical evidence exists to support a stage 3 or 4 diagnosis; as per the discretion of the surgeon, complete surgical staging should include: total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, omental biopsy and lymph node samplings; this is typically the standard unless the disease is bulky or the clinician feels the patient would be best served by chemotherapy and radiation therapy after histologic diagnosis is confirmed
• Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
• Written voluntary informed consent

You may not qualify if:

• Distant metastasis to the lung, bone or brain; typically, most stage 4 uterine papillary serous cancer (UPSC) is confined to the abdomen on presentation
• Serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamate pyruvate transaminase (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/mm\^3
• Absolute neutrophil count (ANC) \< 1500/mm\^3
• 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

• Albert Einstein College of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Interventions

Paclitaxel; Taxes; Carboplatin; Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Coordination Complexes; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Dr. Jessica Atrio, Professor, Department of Obstetrics & Gynecology and Women's Health
• Organization: Albert Einstein College of Medicine - Montefiore Medical center

jatrio@montefiore.org

917-721-6155

Study Officials

• Marina Frimer, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 14, 2014
• Study Start: April 10, 2014
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2017
• Last Updated: August 29, 2023
• Results First Posted: August 29, 2023

Record last verified: 2023-07

Locations

US (1)