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



Status:Completed
Conditions:Cervical Cancer, Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/30/2017
Start Date:July 2005
End Date:December 2009

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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

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.

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.

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
We found this trial at
2
sites
425 E River Pkwy # 754
Minneapolis, Minnesota 55455
612-624-2620
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
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Minneapolis, MN
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3931 Louisiana Ave S
Saint Louis Park, Minnesota 55426
(952) 993-3248
Park Nicollet Cancer Center Park Nicollet Methodist Hospital has a long and rich history in...
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from
Saint Louis Park, MN
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