Back to resultsPhase II Study of Modified Triple Doublet Therapy in Women With Newly Diagnosed Mullerian Carcinoma
Primary Purpose
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chemotherapy, multiple agents
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital
Outcomes
Primary Outcome Measures
· To determine the efficacy of the triple doublet regimen as defined by second look laparotomy
Secondary Outcome Measures
· 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 levels in patients who ultimately achieve pathologic remission vs those with gross residual disease at the time of SLO.
Full Information
NCT ID
NCT00157560
First Posted
September 7, 2005
Last Updated
December 28, 2007
Sponsor
Massachusetts General Hospital
Collaborators
GlaxoSmithKline, Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00157560
Brief Title
Phase II Study of Modified Triple Doublet Therapy in Women With Newly Diagnosed Mullerian Carcinoma
Official Title
A Phase II Trial of ModifiedTriple Doublet Therapy in the Treatment of Women With Newly Diagnosed Carcinoma of Müllerian Origin
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Massachusetts General Hospital
Collaborators
GlaxoSmithKline, Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
83 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Chemotherapy, multiple agents
Primary Outcome Measure Information:
Title
· To determine the efficacy of the triple doublet regimen as defined by second look laparotomy
Secondary Outcome Measure Information:
Title
· To evaluate incidence of tubulin mutations in primary and secondary surgical specimens.
Title
· To evaluate changes in IL-6, IL-8, VEGF, and FGF at primary diagnosis, during and at the conclusion of therapy.
Title
· To describe initial IL-6 levels in patients who ultimately achieve pathologic remission vs those with gross residual disease at the time of SLO.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael V Seiden, M.D. Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.dfhcc.org
Description
Related Info
Learn more about this trial
Phase II Study of Modified Triple Doublet Therapy in Women With Newly Diagnosed Mullerian Carcinoma
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