Endometrial Cancer
Conditions
Keywords
recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma
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.
Interventions
DRUGcarboplatin
Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles.
DRUGdocetaxel
75 mg/m\^2 on Day 1 of each course
RADIATIONradiation therapy
Weekly, 5 days/week over 6-7 weeks (tailored 4500 cGy)
Sponsors
Sanofi
Masonic Cancer Center, University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Estimated to be Progression-Free and Alive | 1 Year, 2 Years, 3 Years | This estimate was determined by using a statistical method of analysis (Kaplan-Meier). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Estimated to be Alive | 1 Year, 2 Years, 3 Years | This estimate of overall survival was determined by using the statistical method (Kaplan-Meier) of analysis. |
Countries
United States
Participant flow
Recruitment details
42 patients consented originally, but 1 patient withdrew consent before receiving any treatment.
Participants by arm
| Arm | Count |
|---|---|
| Patients With Endometrial Cancer Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin. This group excludes those patients with recurrent endometrial cancer. | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | Patients With Endometrial Cancer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 59.0 years STANDARD_DEVIATION 11.5 |
| Histology Adenosquamous | 3 Participants |
| Histology Endometroid | 32 Participants |
| Histology Endometroid + Serous | 1 Participants |
| Histology Mucinous | 1 Participants |
| Histology Serous | 4 Participants |
| Race/Ethnicity, Customized Black | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants |
| Race/Ethnicity, Customized White | 35 Participants |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 41 / 41 |
| serious Total, serious adverse events | 8 / 41 |
Outcome results
Primary
Percent of Patients Estimated to be Progression-Free and Alive
This estimate was determined by using a statistical method of analysis (Kaplan-Meier).
Time frame: 1 Year, 2 Years, 3 Years
Population: Two patients with recurrent disease at study entry were excluded from this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Endometrial Cancer | Percent of Patients Estimated to be Progression-Free and Alive | 1 Year | 86 Percentage of Patients |
| Patients With Endometrial Cancer | Percent of Patients Estimated to be Progression-Free and Alive | 2 Years | 76 Percentage of Patients |
| Patients With Endometrial Cancer | Percent of Patients Estimated to be Progression-Free and Alive | 3 Years | 68 Percentage of Patients |
Secondary
Percent of Patients Estimated to be Alive
This estimate of overall survival was determined by using the statistical method (Kaplan-Meier) of analysis.
Time frame: 1 Year, 2 Years, 3 Years
Population: All 41 patients were included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Endometrial Cancer | Percent of Patients Estimated to be Alive | 1 Year | 94 Percentage of Patients |
| Patients With Endometrial Cancer | Percent of Patients Estimated to be Alive | 2 Years | 91 Percentage of Patients |
| Patients With Endometrial Cancer | Percent of Patients Estimated to be Alive | 3 Years | 80 Percentage of Patients |