Phase II Study of Modified Triple Doublet Therapy in Women With Newly Diagnosed Mullerian Carcinoma - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital GlaxoSmithKline Eli Lilly and Company
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00157560

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer	Drug: Chemotherapy, multiple agents	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Trial of ModifiedTriple Doublet Therapy in the Treatment of Women With Newly Diagnosed Carcinoma of Müllerian Origin

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

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.

Estimated Enrollment:	83
Study Start Date:	December 2000
Study Completion Date:	July 2005
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157560

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

GlaxoSmithKline

Eli Lilly and Company

Investigators

Principal Investigator:

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

Massachusetts General Hospital

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Massachusetts General Hospital ( Maria Roche )
Study ID Numbers:	00-305
Study First Received:	September 7, 2005
Last Updated:	December 28, 2007
ClinicalTrials.gov Identifier:	NCT00157560 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Fallopian Tube Cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases

Fallopian Tube Neoplasms
Carcinoma
Fallopian Tube Diseases
Genital Diseases, Female
Ovarian Cancer
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Fallopian Tube Neoplasms

Adnexal Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on July 06, 2009