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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
This study is not yet open for participant recruitment.
Verified by National Cancer Institute (NCI), October 2007
First Received: August 29, 2006   Last Updated: April 14, 2009   History of Changes
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00369954
  Purpose

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 Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: carboplatin
Drug: gemcitabine hydrochloride
Phase II

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Relative risk of progression-free survival [ Designated as safety issue: No ]
  • Frequency and severity of observed adverse effects by CTCAE version 3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Relative risk of survival [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2006
Estimated Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00369954

Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Noelle G. Cloven, MD Methodist Estabrook Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Gynecologic Oncology Group ( Philip J. DiSaia )
Study ID Numbers: CDR0000496764, GOG-0102H
Study First Received: August 29, 2006
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00369954     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Antimetabolites
Anti-Infective Agents
Fallopian Tube Cancer
Immunologic Factors
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Cisplatin
Peritoneal Diseases
Ovarian Cancer
Gemcitabine
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Carboplatin
Abdominal Neoplasms
Ovarian Epithelial Cancer
Immunosuppressive Agents
Antiviral Agents
Recurrence
Fallopian Tube Neoplasms
Carcinoma
Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Peritoneal Neoplasms
Endocrinopathy

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Gemcitabine
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Carboplatin
Abdominal Neoplasms
Immunosuppressive Agents
Antiviral Agents
Fallopian Tube Neoplasms
Pharmacologic Actions
Adnexal Diseases
Fallopian Tube Diseases
Neoplasms

ClinicalTrials.gov processed this record on August 12, 2009