Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial Cancer

A Phase II Trial of Induction Carboplatin and Docetaxel Followed by Radiotherapy Then Consolidation Chemotherapy With Carboplatin and Docetaxel in Stage III, IV and Recurrent Endometrial Cancer

RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving carboplatin and docetaxel followed by radiation therapy works in treating patients with stage III, stage IV, or recurrent endometrial cancer.

Study Overview

• Status: Completed
• Conditions: Endometrial Cancer
• Intervention / Treatment: Drug: carboplatin; Drug: docetaxel; Radiation: radiation therapy

Detailed Description

OBJECTIVES:

Primary

• Determine the time to progression in patients with stage III or IV or recurrent endometrial cancer treated with induction chemotherapy comprising carboplatin and docetaxel followed by radiotherapy and consolidation chemotherapy comprising carboplatin and docetaxel.

Secondary

• Determine the toxic effects of this regimen in these patients.
• Determine the overall survival of patients treated with this regimen.

OUTLINE: Patients receive docetaxel intravenous (IV) over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses. After hematologic recovery from chemotherapy, patients receive radiotherapy 5 days a week for up to 7 weeks. Beginning 3-4 weeks later, patients receive another 3 courses of docetaxel and carboplatin.

After completion of study treatment, patients are followed periodically for 2 years.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center, University of Minnesota
    • Saint Louis Park, Minnesota, United States, 55426
      • Park Nicollet Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Histologically confirmed endometrial cancer

• Advanced or recurrent disease

  • Stage IIIB or IIIC disease

    • Stage IIIA disease allowed provided there is serosal involvement or direct extension or metastasis to the adnexa
    • No stage IIIA confirmed by only positive peritoneal washings
  • Stage IVA or IVB disease
• Failed local therapy or considered incurable with local therapy

• Measurable or evaluable disease

  • Not required for newly diagnosed stage III or IV disease with no remaining disease after surgery
• Performance status Gynecology Oncology Group (GOG) 0-1
• Life expectancy at least 12 weeks
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10 g/dL

• Meets 1 of the following criteria:

  • Alkaline phosphatase (AP) normal AND aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 5 times upper limit of normal (ULN)
  • AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
  • AP ≤ 5 times ULN AND AST or ALT normal
• Bilirubin normal
• No acute hepatitis
• Creatinine ≤ 1.5 mg/dL

Exclusion Criteria:

• Known hypersensitivity to docetaxel or polysorbate 80
• Severe infection
• Septicemia
• Pregnant or nursing
• Positive pregnancy test
• Fertile patients must use effective nonhormonal contraception during and for at least 3 months after study treatment
• Peripheral neuropathy ≥ grade 2
• Severe gastrointestinal bleeding requiring a blood transfusion or hospitalization
• Other malignancy within the past 5 years except nonmetastatic, nonmelanoma skin cancer or carcinoma in situ of the cervix
• Prior chemotherapy
• Prior radiotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients with Endometrial Cancer; Patients with advanced or current endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (Weekly, 5 days/week over 6-7 weeks, tailored 4500 cGy) and followed by 3 courses of consolidation docetaxel (75 mg/m^2 on Day 1 of each course) /carboplatin (Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles).	Drug: carboplatin; Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles.; Other Names: Gemzar(R); Drug: docetaxel; 75 mg/m^2 on Day 1 of each course; Other Names: Taxotere(R); Radiation: radiation therapy; Weekly, 5 days/week over 6-7 weeks (tailored 4500 cGy); Other Names: radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Patients Estimated to be Progression-Free and Alive	This estimate was determined by using a statistical method of analysis (Kaplan-Meier).	1 Year, 2 Years, 3 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Patients Estimated to be Alive	This estimate of overall survival was determined by using the statistical method (Kaplan-Meier) of analysis.	1 Year, 2 Years, 3 Years

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: November 22, 2005
• First Submitted That Met QC Criteria: November 22, 2005
• First Posted (ESTIMATE): November 24, 2005

Study Record Updates

• Last Update Posted (ACTUAL): December 28, 2017
• Last Update Submitted That Met QC Criteria: December 3, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: stage IV endometrial carcinoma; recurrent endometrial carcinoma; stage III endometrial carcinoma
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Carboplatin
• Other Study ID Numbers: 2004LS021; UMN-WCC-38 (OTHER: Women's Cancer Center, University of Minnesota); 13062 (OTHER: Sanofi-Aventis Pharmaceuticals)