Phase II Study of Modified Triple Doublet Therapy in Women With Newly Diagnosed Mullerian Carcinoma
Completed · Phase 2
Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
In brief
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 that are different from Carboplatin and taxol. This trial looks to evaluate the effectiveness and toxicity of three sequential chemotherapy doublets in the treatment of women with newly diagnosed ovarian, primary peritoneal or tubal carcinoma.
Key facts
- Study ID
- NCT00157560
- Run by
- Massachusetts General Hospital
- People needed
- 83
- Starts
- 2000-12-01
- Expected to finish
- 2005-07-01
- Last updated by the study team
- 2008-01-03
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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