Status:
COMPLETED
Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial Cancer
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborating Sponsors:
Sanofi
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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. Givin...
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 foll...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00258362
Start Date
July 1 2005
End Date
December 1 2009
Last Update
December 28 2017
Active Locations (2)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
2
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55426