Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Endometrial Cancer

NCT01041027 | Terminated Phase 2 Results DMC

• 5 other identifiers: 08-03-060NCI-2013-0122407-062NCI-2012-00458P30CA013330
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well radiation therapy, paclitaxel, and carboplatin work in treating patients with high-risk endometrial cancer. Radiation therapy uses high energy x rays to kill tumor cells. 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, by stopping them from dividing or by stopping them from spreading. Giving radiation therapy with chemotherapy may kill more tumor cells.

Conditions

Endometrial Adenocarcinoma; Stage IA Uterine Corpus Cancer; Stage IB Uterine Corpus Cancer; Stage II Uterine Corpus Cancer; Stage IIIA Uterine Corpus Cancer; Stage IIIB Uterine Corpus Cancer; Stage IIIC Uterine Corpus Cancer; Stage IVA Uterine Corpus Cancer; Stage IVB Uterine Corpus Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  PFS will be analyzed using standard survival analytic methods, including the Kaplan-Meier approach for estimating the survival distribution. Median time to progression and 95% confidence intervals will be estimated from the Kaplan-Meier curves.

  From randomization until documented tumor recurrence or death from any cause, assessed up to 5 years

Secondary Outcomes (8)

• Expression Levels of IGF-1

  Up to 5 years

• Expression Levels of IGF-2

  Up to 5 years

• Expression Levels of IGFBP-1

  Up to 5 years

• Expression Levels of IGFBP-3

  Up to 5 years

• Expression Levels of Insulin Receptor

  Up to 5 years

Study Arms (1)

Treatment (paclitaxel, carboplatin, radiation therapy)

EXPERIMENTAL

CHEMOTHERAPY (weeks 1-9, 13-21): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 3 courses during weeks 13-21. RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo HDR brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo EBRT QD 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15.

Drug: Paclitaxel; Drug: Carboplatin; Radiation: Internal Radiation Therapy; Radiation: External Beam Radiation Therapy; Other: Laboratory Biomarker Analysis

Interventions

Paclitaxel DRUG

Given IV

Also known as: Anzatax, TAX

Treatment (paclitaxel, carboplatin, radiation therapy)

Carboplatin DRUG

Given IV

Treatment (paclitaxel, carboplatin, radiation therapy)

Internal Radiation Therapy RADIATION

Undergo HDR brachytherapy

Also known as: Brachytherapy, Internal Radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy

Treatment (paclitaxel, carboplatin, radiation therapy)

External Beam Radiation Therapy RADIATION

Undergo EBRT

Also known as: Definitive Radiation Therapy, EBRT, External Beam RT

Treatment (paclitaxel, carboplatin, radiation therapy)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (paclitaxel, carboplatin, radiation therapy)

Eligibility Criteria

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

You may qualify if:

• Histologically-documented high-risk endometrioid adenocarcinoma with no visible residual disease, defined by the following criteria:
• Surgical stage I disease with \< 50 myometrial invasion and grade 3 tumor (IAG3) with lymphovascular space involvement;
• Surgical stage I disease with \>= 50% myometrial invasion and grade 2 or 3 tumor (IBG2, IBG3);
• Any surgical stage II disease (II);
• Any surgical stage III disease (IIIA, IIIB, IIIC); and
• Any surgical stage IV disease with no residual macroscopic tumor
• Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings as per standard Gynecologic Oncology Group (GOG) criteria
• Eastern Cooperative Oncology Group (ECOG) performance status of \< 2
• Written voluntary informed consent

You may not qualify if:

• Serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) \> 2.5 times the institutional upper limit of normal
• Total serum bilirubin \> 1.5 mg/dl
• History of chronic or active hepatitis
• 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)
• Patient has severe or uncontrolled concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
• Patient with any prior chemotherapy or radiotherapy for pelvic malignancy
• Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry
• Patients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five years

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; Brachytherapy

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Dennis Yi-Shin Kuo
• Organization: Montefiore Medical Center

dykuo@montefiore.org

718-405-8086

Study Officials

• Dennis Yi-Shin Kuo

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: December 29, 2009
• First Posted: December 30, 2009
• Study Start: January 16, 2009
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 26, 2023
• Results First Posted: October 26, 2023

Record last verified: 2023-10

Locations

US (1)