search
Back to results

Gemcitabine and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Responded to Previous Cisplatin or Carboplatin

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
carboplatin
gemcitabine hydrochloride
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer Persistent or recurrent disease Nonmeasurable disease Platinum-sensitive disease Must have attained a clinically defined complete response after prior platinum- (cisplatin or carboplatin) and taxane-based combination chemotherapy regimen Patients with partial response or disease progression after first-line therapy are not eligible No disease recurrence within 6 months after completion of first-line platinum-taxane therapy Must have undergone laparoscopy or laparotomy for either of the following: Second-look surgery after a complete response to first-line therapy No negative second-look surgery Secondary cytoreductive surgery for recurrent disease ≥ 6 months after completion of first-line chemotherapy No greater than 1 cm residual disease at the completion of laparoscopy or laparotomy AND no diffuse carcinomatosis Disease must be confined to the peritoneal cavity Retroperitoneal disease ≤ 1 cm at the completion of prior surgery allowed Not a candidate for a higher priority GOG protocol No tumors of low malignant potential PATIENT CHARACTERISTICS: GOG performance status 0-2 Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Creatinine ≤ 1.5 times upper limit of normal (ULN) Bilirubin ≤ 1.5 times ULN SGOT ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Neuropathy (sensory and motor) ≤ grade 1 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection requiring antibiotics No other invasive malignancies within the past 5 years except nonmelanoma skin cancer No extensive intra-abdominal adhesions PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from prior surgery or chemotherapy No prior intraperitoneal therapy No prior gemcitabine hydrochloride No more than 1 prior regimen (including consolidation chemotherapy) for ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer No radiotherapy to > 25% of marrow-bearing areas No prior abdominal-pelvic radiotherapy No prior cancer treatment that would preclude study therapy No other prior therapy directed at the malignant tumor, including biological agents (unless this was part of front-line therapy), immunologic agents, vaccines, second-line chemotherapy, or hormonal therapy Concurrent hormone replacement therapy allowed No concurrent amifostine or other protective reagents

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Relative risk of progression-free survival
    Frequency and severity of observed adverse effects by CTCAE version 3.0

    Secondary Outcome Measures

    Relative risk of survival

    Full Information

    First Posted
    August 29, 2006
    Last Updated
    June 7, 2013
    Sponsor
    Gynecologic Oncology Group
    Collaborators
    National Cancer Institute (NCI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00369954
    Brief Title
    Gemcitabine and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Responded to Previous Cisplatin or Carboplatin
    Official Title
    A Phase II Trial of Intravenous Gemcitabine (NSC #613327) and Intraperitoneal Carboplatin (NSC # 241240) in the Treatment of Patients With Platinum-Sensitive Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma With Non-Measurable Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2007
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Trial was never activated
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Gynecologic Oncology Group
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine together with carboplatin works in treating patients with persistent or recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that responded to previous cisplatin or carboplatin.
    Detailed Description
    OBJECTIVES: Primary Determine the progression-free survival of patients with persistent or recurrent platinum-sensitive ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with gemcitabine hydrochloride and intraperitoneal carboplatin. Evaluate the systemic and regional toxicity of this regimen in these patients. Secondary Determine the overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive gemcitabine hydrochloride IV over 30 minutes followed by intraperitoneal carboplatin on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 3 years. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
    Keywords
    recurrent ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    carboplatin
    Intervention Type
    Drug
    Intervention Name(s)
    gemcitabine hydrochloride
    Primary Outcome Measure Information:
    Title
    Relative risk of progression-free survival
    Title
    Frequency and severity of observed adverse effects by CTCAE version 3.0
    Secondary Outcome Measure Information:
    Title
    Relative risk of survival

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer Persistent or recurrent disease Nonmeasurable disease Platinum-sensitive disease Must have attained a clinically defined complete response after prior platinum- (cisplatin or carboplatin) and taxane-based combination chemotherapy regimen Patients with partial response or disease progression after first-line therapy are not eligible No disease recurrence within 6 months after completion of first-line platinum-taxane therapy Must have undergone laparoscopy or laparotomy for either of the following: Second-look surgery after a complete response to first-line therapy No negative second-look surgery Secondary cytoreductive surgery for recurrent disease ≥ 6 months after completion of first-line chemotherapy No greater than 1 cm residual disease at the completion of laparoscopy or laparotomy AND no diffuse carcinomatosis Disease must be confined to the peritoneal cavity Retroperitoneal disease ≤ 1 cm at the completion of prior surgery allowed Not a candidate for a higher priority GOG protocol No tumors of low malignant potential PATIENT CHARACTERISTICS: GOG performance status 0-2 Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Creatinine ≤ 1.5 times upper limit of normal (ULN) Bilirubin ≤ 1.5 times ULN SGOT ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Neuropathy (sensory and motor) ≤ grade 1 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection requiring antibiotics No other invasive malignancies within the past 5 years except nonmelanoma skin cancer No extensive intra-abdominal adhesions PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from prior surgery or chemotherapy No prior intraperitoneal therapy No prior gemcitabine hydrochloride No more than 1 prior regimen (including consolidation chemotherapy) for ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer No radiotherapy to > 25% of marrow-bearing areas No prior abdominal-pelvic radiotherapy No prior cancer treatment that would preclude study therapy No other prior therapy directed at the malignant tumor, including biological agents (unless this was part of front-line therapy), immunologic agents, vaccines, second-line chemotherapy, or hormonal therapy Concurrent hormone replacement therapy allowed No concurrent amifostine or other protective reagents
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Noelle G. Cloven, MD
    Organizational Affiliation
    Methodist Estabrook Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Gemcitabine and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Responded to Previous Cisplatin or Carboplatin

    We'll reach out to this number within 24 hrs