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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00369954 |
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 |
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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 |
Estimated Enrollment: | 100 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer
Platinum-sensitive disease
Must have attained a clinically defined complete response after prior platinum- (cisplatin or carboplatin) and taxane-based combination chemotherapy regimen
Must have undergone laparoscopy or laparotomy for either of the following:
Second-look surgery after a complete response to first-line therapy
Disease must be confined to the peritoneal cavity
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT 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
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 |
recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
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 |
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 |