Clinical trial NCT00258362: Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometrial Cancer
Keywords: recurrent endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-11-24
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Percent of Patients Estimated to be Progression-Free and Alive
timeFrame: 1 Year, 2 Years, 3 Years
Secondary outcomes:
measure: Percent of Patients Estimated to be Alive
timeFrame: 1 Year, 2 Years, 3 Years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Cancer Center
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Melissa A. Geller, MD
role: PRINCIPAL_INVESTIGATOR
References: