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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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
carboplatin
gemcitabine hydrochloride
paclitaxel
Sponsored by
Warwick Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring ovarian carcinosarcoma, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer, stage IIIA primary peritoneal cavity cancer, stage IIIB primary peritoneal cavity cancer, stage IIIC primary peritoneal cavity cancer, stage IV primary peritoneal cavity cancer, stage IIIA fallopian tube cancer, stage IIIB fallopian tube cancer, stage IIIC fallopian tube cancer, stage IV fallopian tube cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
  • Good Hope Hospital
  • Birmingham Heartlands Hospital
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm Description

Patients receive carboplatin IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo treatment with paclitaxel and may also receive 6 more courses of neoadjuvant chemotherapy. Patients may then undergo surgery. After surgery, patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients receive carboplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo treatment with paclitaxel and may also receive 6 more courses of neoadjuvant chemotherapy. Patients may then undergo surgery. After surgery, patients receive paclitaxel IV over 3 hours and gemcitabine hydrochloride IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Percentage of patients completing 12 courses of chemotherapy

Secondary Outcome Measures

Toxicity
Quality of life as assessed by FACT-G, FACT-0, and FACT-T periodically
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
Objective response rate following all 12 courses of treatment assessed clinically, by CT scan, and by CA-125 level
Progression-free survival, particularly at 34 weeks
Overall survival, particularly at 34 weeks
Rates of optimal and suboptimal interval debulking

Full Information

First Posted
February 5, 2009
Last Updated
September 16, 2013
Sponsor
Warwick Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT00838656
Brief Title
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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Warwick Medical School

4. Oversight

5. Study Description

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 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.
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 feasibility of extended sequential regimens offering 6+6 courses of chemotherapy in patients presenting with inoperable disease. To establish the feasibility of biweekly paclitaxel with vs without gemcitabine hydrochloride in the adjuvant phase, after carboplatin neoadjuvant induction. OUTLINE: This is a multicenter study. Patients are stratified according to serum albumin (< 30 g/dL vs 30-35 g/dL vs > 35 g/dL), FIGO stage (stage IIIC vs stage IV), and histological grade (well-differentiated [grade 1] vs moderately well-differentiated [grade 2] vs poorly differentiated [grade 3]). Patients are randomized to 1 of 2 treatment arms. Neoadjuvant therapy: Arm I: Patients receive carboplatin IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive carboplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. In both arms, patients with disease progression are switched to adjuvant paclitaxel-based chemotherapy. Patients with responding disease after switching regimens may undergo debulking surgery at the investigator's discretion. Surgery: After completion of 6 courses of chemotherapy, all patients are evaluated for surgery. Patients with questionable operability based on clinical or radiological criteria are re-assessed laparoscopically. Patients judged to have disease that is amenable to optimal debulking at laparotomy are recommended for debulking surgery. Patients judged to have disease that is not amenable to optimal debulking are reconsidered for surgery after they receive an additional 6 courses of chemotherapy. Patients with disease progression after completion of 12 courses of chemotherapy undergo laparotomy only if there is a clinically pressing need to palliate their condition and if surgery offers some prospect of achieving this result (e.g., palliation for bowel obstruction). Adjuvant therapy: Arm I: Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive paclitaxel IV over 3 hours and gemcitabine hydrochloride IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients complete quality of life questionnaires at baseline, after completion of course 6 of neoadjuvant therapy, before course 7, and at the end of study treatment. After completion of study therapy, patients are followed periodically for up to 10 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
ovarian carcinosarcoma, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer, stage IIIA primary peritoneal cavity cancer, stage IIIB primary peritoneal cavity cancer, stage IIIC primary peritoneal cavity cancer, stage IV primary peritoneal cavity cancer, stage IIIA fallopian tube cancer, stage IIIB fallopian tube cancer, stage IIIC fallopian tube cancer, stage IV fallopian tube cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive carboplatin IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo treatment with paclitaxel and may also receive 6 more courses of neoadjuvant chemotherapy. Patients may then undergo surgery. After surgery, patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive carboplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo treatment with paclitaxel and may also receive 6 more courses of neoadjuvant chemotherapy. Patients may then undergo surgery. After surgery, patients receive paclitaxel IV over 3 hours and gemcitabine hydrochloride IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
Given IV in one of two schedules
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Description
Given IV in one of two schedules
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
Given IV in one of two schedules
Primary Outcome Measure Information:
Title
Percentage of patients completing 12 courses of chemotherapy
Secondary Outcome Measure Information:
Title
Toxicity
Title
Quality of life as assessed by FACT-G, FACT-0, and FACT-T periodically
Title
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
Title
Objective response rate following all 12 courses of treatment assessed clinically, by CT scan, and by CA-125 level
Title
Progression-free survival, particularly at 34 weeks
Title
Overall survival, particularly at 34 weeks
Title
Rates of optimal and suboptimal interval debulking

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Poole, MD
Organizational Affiliation
University Hospital Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Good Hope Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B75 7RR
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
State/Province
England
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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