- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00369954
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
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
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Relative risk of progression-free survival
|
Frequency and severity of observed adverse effects by CTCAE version 3.0
|
Secondary Outcome Measures
Outcome Measure |
---|
Relative risk of survival
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Noelle G. Cloven, MD, Methodist Estabrook Cancer Center
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Adnexal Diseases
- Fallopian Tube Diseases
- Fallopian Tube Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Carboplatin
Other Study ID Numbers
- CDR0000496764
- GOG-0102H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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