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A Phase II Trial of ModifiedTriple Doublet Therapy in the Treatment of Women With Newly Diagnosed Carcinoma of Müllerian Origin

Phase 2
18 Years
Not Enrolling
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

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Trial Information

A Phase II Trial of ModifiedTriple Doublet Therapy in the Treatment of Women With Newly Diagnosed Carcinoma of Müllerian Origin

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 achieving either a pathologic complete response or a microscopic positive second
look at the conclusion of therapy.

Primary study goals:

· To determine the efficacy of a triple doublet regimen in carefully defined cohorts of
patients as defined by the surgical defined response rate

Secondary study goals:

- To evaluate incidence of tubulin mutations in primary and secondary surgical specimens.

- To evaluate changes in IL-6, IL-8, VEGF, and FGF, at primary diagnosis, during and at
the conclusion of therapy.

- To describe initial IL-6, IL-8, and FGF levels in patients who ultimately achieve
pathologic remission vs those with gross residual disease.

Patients will recieve 3 cycles of carboplatin and gemcitabine followed by 3 cycles of taxol
and carboplatin and then three cycles of adriamycin and topotecan. All patients with a
clinically complete response will then undergo second look operation to determine
pathologically defined response.

- SLO = Second Look Operation

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

· To determine the efficacy of the triple doublet regimen as defined by second look laparotomy

Principal Investigator

Michael V Seiden, M.D. Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

December 2000

Completion Date:

July 2005

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • Carcinoma
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Massachusetts General Hospital Boston, Massachusetts  02114-2617