Phase II Study of Modified Triple Doublet Therapy in Women With Newly Diagnosed Mullerian Carcinoma

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157560
• Other study ID #: 00-305
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: December 28, 2007
• Start date: December 2000
• Est. completion date: July 2005

Study information

• Verified date: December 2007
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: July 2005
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cancer

Intervention

Drug:
• Chemotherapy, multiple agents

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Eli Lilly and Company, GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	· To determine the efficacy of the triple doublet regimen as defined by second look laparotomy
Secondary	· To evaluate incidence of tubulin mutations in primary and secondary surgical specimens.
Secondary	· To evaluate changes in IL-6, IL-8, VEGF, and FGF at primary diagnosis, during and at the conclusion of therapy.
Secondary	· To describe initial IL-6 levels in patients who ultimately achieve pathologic remission vs those with gross residual disease at the time of SLO.

External Links

•   Link