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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00258362
First received: November 22, 2005
Last updated: November 6, 2012
Last verified: November 2012
  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
Radiation: radiation therapy
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Percent of Patients Estimated to be Progression-Free and Alive [ Time Frame: 1 Year, 2 Years, 3 Years ] [ Designated as safety issue: Yes ]
    This estimate was determined by using a statistical method of analysis (Kaplan-Meier).


Secondary Outcome Measures:
  • Percent of Patients Estimated to be Alive [ Time Frame: 1 Year, 2 Years, 3 Years ] [ Designated as safety issue: No ]
    This estimate of overall survival was determined by using the statistical method (Kaplan-Meier) of analysis.


Enrollment: 41
Study Start Date: July 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Gemzar(R)
Drug: docetaxel
75 mg/m^2 on Day 1 of each course
Other Name: Taxotere(R)
Radiation: radiation therapy
Weekly, 5 days/week over 6-7 weeks (tailored 4500 cGy)
Other Name: radiation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258362

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Park Nicollet Cancer Center
St. Louis Park, Minnesota, United States, 55426
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Sanofi
Investigators
Principal Investigator: Melissa A. Geller, MD Masonic Cancer Center, University of Minnesota
  More Information

Additional Information:
No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00258362     History of Changes
Other Study ID Numbers: 2004LS021, UMN-WCC-38, 13062
Study First Received: November 22, 2005
Results First Received: August 20, 2010
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:
recurrent endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Docetaxel
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014