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Status:

UNKNOWN

Two Different Schedules of Carboplatin, Paclitaxel, Gemcitabine, and Surgery in Treating Patients With Newly Diagnosed Stage IIIC or Stage IV Primary Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Lead Sponsor:

Warwick Medical School

Conditions:

Fallopian Tube Cancer

Ovarian Cancer

Eligibility:

FEMALE

18-75 years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, gemcitabine, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from ...

Detailed Description

OBJECTIVES: * To examine and compare the feasibility of two sequential neoadjuvant regimens in patients with newly diagnosed, stage IIIC-IV ovarian or peritoneal carcinoma. * To confirm the feasibili...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Clinically, radiologically, and histologically confirmed diagnosis of 1 of the following:
  • Primary epithelial ovarian cancer
  • Primary peritoneal carcinoma
  • Ovarian carcinosarcoma
  • Fallopian tube carcinoma
  • Newly diagnosed, stage IIIC/IV disease with or without ascites
  • None of the following histologies allowed:
  • Mucinous
  • Classic clear cell
  • Micropapillary or microacinar borderline tumors with or without invasive implants
  • Unsuitable for primary debulking surgery, as defined by the following:
  • Laparoscopic or other minor surgical-staging procedures
  • Supplementary clinical and radiological assessments
  • Presenting with factors affecting suitability for successful complete resection and necessarily prompting laparoscopic assessment, including any of the following:
  • CT scan or MRI evidence of peritoneal carcinomatosis, extensive mesenteric infiltration, diaphragmatic involvement, extensive retroperitoneal involvement, and cytologically verified malignant pleural effusion and/or ascites
  • Clinical evidence of ascites with radiological evidence of multisite disease
  • Clinical evidence of pelvic infiltration and radiological evidence of multisite disease
  • FIGO stage IV disease, including cervical/supraclavicular lymphadenopathy, intrahepatic parenchymal metastases, or cytologically confirmed malignant pleural effusion
  • No known brain metastases
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-3
  • Life expectancy ≥ 3 months
  • WBC \> 3.0/mm³
  • Platelet count ≥ 100,000/mm³
  • ANC ≥ 1,500/mm³
  • AST and ALT \< 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase \< 2.5 times ULN
  • Bilirubin \< 1.5 times ULN
  • Estimated glomerular filtration rate ≥ 30 mL/min
  • No diabetics, hypertensive smokers, or other patients with pre-existing occult neuropathic deficits
  • No poorly controlled, potentially serious medical conditions, including any of the following:
  • Cerebrovascular events within the past 12 months
  • Severe chronic respiratory conditions requiring prior hospitalization
  • Active infections
  • Poorly controlled seizures
  • Morbid psychiatric conditions likely to render treatment compliance with the protocol difficult
  • No other malignancy treated with chemotherapy or radiotherapy except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • Prior malignancies disease-free for \> 5 years not treated with chemotherapy allowed
  • No other reasons likely to cause inability to comply with treatment schedule and follow-up
  • Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics

Exclusion

    Key Trial Info

    Start Date :

    October 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    88 Patients enrolled

    Trial Details

    Trial ID

    NCT00838656

    Start Date

    October 1 2007

    Last Update

    September 17 2013

    Active Locations (4)

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    Page 1 of 1 (4 locations)

    1

    Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

    Birmingham, England, United Kingdom, B15 2TH

    2

    Good Hope Hospital

    Birmingham, England, United Kingdom, B75 7RR

    3

    Birmingham Heartlands Hospital

    Birmingham, England, United Kingdom, B9 5SS

    4

    New Cross Hospital

    Wolverhampton, England, United Kingdom, WV10 0QP