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

Endometrial Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258362
• Other study ID #: 2004LS021
• Secondary ID: UMN-WCC-3813062
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2005
• Last updated: December 3, 2017
• Start date: July 2005
• Est. completion date: December 2009

Study information

• Verified date: December 2017
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Drug:
• carboplatin
Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles.
• docetaxel
75 mg/m^2 on Day 1 of each course

Radiation:
• radiation therapy
Weekly, 5 days/week over 6-7 weeks (tailored 4500 cGy)

Locations

Country	Name	City	State
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota
United States	Park Nicollet Cancer Center	Saint Louis Park	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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