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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

Phase 2
18 Years
Not Enrolling
Endometrial Cancer

Thank you

Trial Information

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



- 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.


- 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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percent of Patients Estimated to be Progression-Free and Alive

Outcome Description:

This estimate was determined by using a statistical method of analysis (Kaplan-Meier).

Outcome Time Frame:

1 Year, 2 Years, 3 Years

Safety Issue:


Principal Investigator

Melissa A. Geller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

July 2005

Completion Date:

December 2009

Related Keywords:

  • Endometrial Cancer
  • recurrent endometrial carcinoma
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455