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

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ClinicalTrials.gov Identifier: NCT00157560
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 3, 2008
Sponsor:
Collaborators:
GlaxoSmithKline
Eli Lilly and Company
Information provided by:
Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Drug: Chemotherapy, multiple agents Phase 2

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 83 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of ModifiedTriple Doublet Therapy in the Treatment of Women With Newly Diagnosed Carcinoma of Müllerian Origin
Study Start Date : December 2000
Actual Primary Completion Date : November 2006
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. · To determine the efficacy of the triple doublet regimen as defined by second look laparotomy

Secondary Outcome Measures :
  1. · To evaluate incidence of tubulin mutations in primary and secondary surgical specimens.
  2. · To evaluate changes in IL-6, IL-8, VEGF, and FGF at primary diagnosis, during and at the conclusion of therapy.
  3. · To describe initial IL-6 levels in patients who ultimately achieve pathologic remission vs those with gross residual disease at the time of SLO.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Maria Roche, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00157560     History of Changes
Other Study ID Numbers: 00-305
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 3, 2008
Last Verified: December 2007

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female