Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial Cancer
This study has been completed.
Sponsor:
Masonic Cancer Center, University of Minnesota
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
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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
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 Sarcoma, Endometrial Stromal Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed |
Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Neoplasms, Glandular and Epithelial Docetaxel Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013