Status:
COMPLETED
Phase II Study of Modified Triple Doublet Therapy in Women With Newly Diagnosed Mullerian Carcinoma
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
GlaxoSmithKline
Eli Lilly and Company
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Over the last few years several novel agents have been defined which are active in the treatment of relapsed epithelial ovarian carcinoma. Many of these new agents seemed to have mechanisms of action ...
Detailed Description
Objective: To evaluate a novel regimen in ovarian carcinoma with an aim of demonstrating a higher than 50% laparotomy defined response rate. This rate is defined as the proportion of patients achievin...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed epithelial carcinoma of müllerian origin. Specifically, ovarian, primary peritoneal and tubal carcinoma will be allowed. All histologic subtypes are eligible.
- Patients must have undergone an attempt at aggressive surgical debulking or alternatively be eligible for interim debulking after cycle #3. Patients debulked to no evidence of disease, microscopic disease or gross residual disease are eligible.
- Stage II, III or IV disease. Patients with disease outside the abdominal cavity are eligible unless presentation includes brain metastases.
- Able and willing to undergo a second look staging laparotomy.
- Patients must give written informed consent.
- Patient must be ag· Performance status (ECOG) \>2.
- Previous chemotherapy.
- Creatinine \> 1.5
- History of recent MI or congestive heart failure within 6 months of surgery
- SGOT \> 2x ULN, bilirubin \> 1.5 X ULN
- Concurrent invasive malignancy. (Patients with concurrent superficial endometrial carcinoma are eligible if their endometrial carcinoma is superficial or invades less than 50% the thickness of the myometrium).
- Known hypersensitivity to E.coli derived products?
- Active psychiatric or mental illness that makes informed consent or careful clinical follow-up unlikely e 18 years or older.
- Adequate bone marrow function with an ANC \> 2,500 and Platelets \>100,000/mm3.
- Exclusion Criteria
Exclusion
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00157560
Start Date
December 1 2000
End Date
July 1 2005
Last Update
January 3 2008
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114