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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00838656
First received: February 5, 2009
Last updated: September 16, 2013
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: carboplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Percentage of patients completing 12 courses of chemotherapy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Quality of life as assessed by FACT-G, FACT-0, and FACT-T periodically [ Designated as safety issue: 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 [ Designated as safety issue: No ]
  • Objective response rate following all 12 courses of treatment assessed clinically, by CT scan, and by CA-125 level [ Designated as safety issue: No ]
  • Progression-free survival, particularly at 34 weeks [ Designated as safety issue: No ]
  • Overall survival, particularly at 34 weeks [ Designated as safety issue: No ]
  • Rates of optimal and suboptimal interval debulking [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: October 2007
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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. 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.
Drug: carboplatin
Given IV in one of two schedules
Drug: gemcitabine hydrochloride
Given IV in one of two schedules
Drug: paclitaxel
Given IV in one of two schedules
Experimental: 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. 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.
Drug: carboplatin
Given IV in one of two schedules
Drug: gemcitabine hydrochloride
Given IV in one of two schedules
Drug: paclitaxel
Given IV in one of two schedules

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838656

Locations
United Kingdom
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom, B9 5SS
Good Hope Hospital
Birmingham, England, United Kingdom, B75 7RR
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
New Cross Hospital
Wolverhampton, England, United Kingdom, WV10 0QP
Sponsors and Collaborators
Warwick Medical School
Investigators
Principal Investigator: Christopher Poole, MD University Hospital Birmingham
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00838656     History of Changes
Other Study ID Numbers: CDR0000632859, WMS-NEOESCAPE-AK/RH/22498/1, ISRCTN24742183, EUDRACT-2005-001875-37, EU-20904, MREC-07/Q2803/73, RG_05-003
Study First Received: February 5, 2009
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Carboplatin
Gemcitabine
Paclitaxel
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors

ClinicalTrials.gov processed this record on October 23, 2014