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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

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ClinicalTrials.gov Identifier: NCT00369954
Recruitment Status : Withdrawn (Trial was never activated)
First Posted : August 30, 2006
Last Update Posted : June 10, 2013
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group

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.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer Drug: carboplatin Drug: gemcitabine hydrochloride Phase 2

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
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 Start Date : April 2006

Primary Outcome Measures :
  1. Relative risk of progression-free survival
  2. Frequency and severity of observed adverse effects by CTCAE version 3.0

Secondary Outcome Measures :
  1. Relative risk of survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00369954

Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Noelle G. Cloven, MD Methodist Estabrook Cancer Center

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00369954     History of Changes
Other Study ID Numbers: CDR0000496764
First Posted: August 30, 2006    Key Record Dates
Last Update Posted: June 10, 2013
Last Verified: October 2007

Keywords provided by Gynecologic Oncology Group:
recurrent ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs