|
Health Condition(s) or Problem
|
Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer
|
|
Lay Summary
|
http://www.cancerhelp.org.uk/trials/a-trial-looking-at-chemotherapy-before-and-after-surgery-for-advanced-peritoneal-cancer (from ISRCTN)
Additional lay summaries...
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.
(from ClinicalTrials.gov)
|
|
Who can enter the trial
|
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
|
|
Who cannot enter the trial
|
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
|
|
What will happen
|
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
|
|
Primary aim
|
Percentage of patients completing 12 courses of chemotherapy
|
|
Secondary Aim
|
Toxicity; Yes; Quality of life as assessed by FACT-G, FACT-0, and FACT-T periodically; No; 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; No; Objective response rate following all 12 courses of treatment assessed clinically, by CT scan, and by CA-125 level; No; Progression-free survival, particularly at 34 weeks; No; Overall survival, particularly at 34 weeks; No; Rates of optimal and suboptimal interval debulking; No
|
|
Participant Information Sheet
|
Sorry, not currently available
|
|
Website
|
Sorry, not currently available
|
|
Recruitment Status
|
Recruiting
|
|
Nation
|
England
|
|
Location
|
Birmingham, Sutton Coldfield, Wolverhampton
|