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
Recruitment status was Not yet recruiting
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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 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
- 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 ]
- 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) |
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 |
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
More Information
No publications provided
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00369954 History of Changes |
| Other Study ID Numbers: | CDR0000496764, GOG-0102H |
| Study First Received: | August 29, 2006 |
| Last Updated: | April 14, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Neoplasms by Histologic Type Gemcitabine Carboplatin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 21, 2013