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 | Not Recruiting
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
Health Conditions
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
Not Recruiting
Recruitment Status
NCT00838656
Primary Trial ID Number
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 dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known which treatment regimen may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving one of two chemotherapy regimens containing carboplatin, gemcitabine, and paclitaxel works in treating patients undergoing surgery for newly diagnosed primary stage IIIC or stage IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Primary Outcome Measures
  • Percentage of patients completing 12 courses of chemotherapy; null
Secondary Outcome Measures
  • Toxicity; null; Quality of life as assessed by FACT-G, FACT-0, and FACT-T periodically; null; Objective response rate to the neoadjuvant phase of chemotherapy (i.e., first 6 courses) as assessed by CT scan, by laparoscopy, clinically, and by CA-125 level; null; Objective response rate following all 12 courses of treatment assessed clinically, by CT scan, and by CA-125 level; null; Progression-free survival, particularly at 34 weeks; null; Overall survival, particularly at 34 weeks; null; Rates of optimal and suboptimal interval debulking; null
Research Question
  • 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 dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known which treatment regimen may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving one of two chemotherapy regimens containing carboplatin, gemcitabine, and paclitaxel works in treating patients undergoing surgery for newly diagnosed primary stage IIIC or stage IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Female
Participant Age Range
18 Years to 75 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
88
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
  • 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
Interventions
Drug; carboplatin; Given IV in one of two schedules; [Arm I, Arm II]; Drug; gemcitabine hydrochloride; Given IV in one of two schedules; [Arm I, Arm II]; Drug; paclitaxel; Given IV in one of two schedules; [Arm I, Arm II]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
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Scientific Title
A Randomised Feasibility Study of Extended Chemotherapy With Neoadjuvant Carboplatin, Then Surgery Followed by Adjuvant Paclitaxel and Gemcitabine Verses Neoadjuvant Gemcitabine and Carboplatin, Then Surgery, Followed by Adjuvant Paclitaxel
Secondary Trial Identifying Number
WMS-NEOESCAPE-AK/RH/22498/1; ISRCTN24742183; EUDRACT-2005-001875-37; EU-20904; MREC-07/Q2803/73; RG_05-003
Website
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Study Funded By
Warwick Medical School
Funder Type
Sorry, this information is not available
Study Sponsored By
Warwick Medical School
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

05 Feb 2009

Last Updated

16 Sep 2013

Date Record Refreshed on UKCTG

31 Jul 2015