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Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008
Sponsors and Collaborators: Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00258362
  Purpose

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.


Condition Intervention Phase
Endometrial Cancer
Drug: carboplatin
Drug: docetaxel
Procedure: radiation therapy
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Carboplatin Docetaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Study Start Date: July 2005
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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 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.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Performance status

  • GOG 0-1

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL

Hepatic

  • Meets 1 of the following criteria:

    • Alkaline phosphatase (AP) normal AND AST or 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

Renal

  • Creatinine ≤ 1.5 mg/dL

Immunologic

  • No known hypersensitivity to docetaxel or polysorbate 80
  • No severe infection
  • No septicemia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception during and for at least 3 months after study treatment
  • No peripheral neuropathy ≥ grade 2
  • No severe gastrointestinal bleeding requiring a blood transfusion or hospitalization
  • No other malignancy within the past 5 years except nonmetastatic, nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No prior chemotherapy

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258362

Locations
United States, Minnesota
Masonic Cancer Center at University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o     612-624-2620        
Park Nicollet Cancer Center Recruiting
St. Louis Park, Minnesota, United States, 55426
Contact: Rahel Ghebre, MD     952-993-6705        
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Study Chair: Melissa A. Geller, MD Masonic Cancer Center, University of Minnesota
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Masonic Cancer Center at University of Minnesota ( Melissa A. Geller )
Study ID Numbers: CDR0000450981, UMN-2004LS021, UMN-WCC-38
Study First Received: November 22, 2005
Last Updated: October 24, 2008
ClinicalTrials.gov Identifier: NCT00258362  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma

Study placed in the following topic categories:
Docetaxel
Genital Diseases, Female
Endometrial Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Carboplatin
Endometrial cancer
Recurrence
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009