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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Relative risk of progression-free survival

Safety Issue:

No

Principal Investigator

Noelle G. Cloven, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Methodist Estabrook Cancer Center

Authority:

Unspecified

Study ID:

CDR0000496764

NCT ID:

NCT00369954

Start Date:

April 2006

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

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