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

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
docetaxel
radiation therapy
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Masonic Cancer Center, University of Minnesota
  • Park Nicollet Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with Endometrial Cancer

Arm Description

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).

Outcomes

Primary Outcome Measures

Percent of Patients Estimated to be Progression-Free and Alive
This estimate was determined by using a statistical method of analysis (Kaplan-Meier).

Secondary Outcome Measures

Percent of Patients Estimated to be Alive
This estimate of overall survival was determined by using the statistical method (Kaplan-Meier) of analysis.

Full Information

First Posted
November 22, 2005
Last Updated
December 3, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00258362
Brief Title
Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with Endometrial Cancer
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Gemzar(R)
Intervention Description
Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles.
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
Taxotere(R)
Intervention Description
75 mg/m^2 on Day 1 of each course
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
radiation
Intervention Description
Weekly, 5 days/week over 6-7 weeks (tailored 4500 cGy)
Primary Outcome Measure Information:
Title
Percent of Patients Estimated to be Progression-Free and Alive
Description
This estimate was determined by using a statistical method of analysis (Kaplan-Meier).
Time Frame
1 Year, 2 Years, 3 Years
Secondary Outcome Measure Information:
Title
Percent of Patients Estimated to be Alive
Description
This estimate of overall survival was determined by using the statistical method (Kaplan-Meier) of analysis.
Time Frame
1 Year, 2 Years, 3 Years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa A. Geller, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Park Nicollet Cancer Center
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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