Phase 2 Completed N=41 Treatment

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

Source: ClinicalTrials.gov NCT00258362 ↗

Enrolled (actual)

Serious AEs

19.5%

Results posted

Nov 2010

Primary outcomePrimary: Percent of Patients Estimated to be Progression-Free and Alive — 86; 76; 68 Percentage of Patients

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Patients Estimated to be Progression-Free and Alive	86; 76; 68	—
SECONDARY Percent of Patients Estimated to be Alive	94; 91; 80	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00258362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.