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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Relative risk of progression-free survival
Secondary Outcome
Relative risk of survival
Condition
Fallopian Tube Cancer
Intervention
carboplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
April 2006
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Noelle G. Cloven, MD, ,
Administrative Informations
NCT ID
NCT00369954
Organization ID
CDR0000496764
Secondary IDs
GOG-0102H
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Noelle G. Cloven, MD, Study Chair, Methodist Estabrook Cancer Center
Verification Date
October 2007