Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Adjuvant Intraperitoneal Carboplatin With Paclitaxel in Treating Patients Who Had Initial Debulking Surgery for Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Active 18 and over NCI GOG-9917 NCT00079430

Objectives

Primary

1. Determine the maximum tolerated dose of intraperitoneal carboplatin when administered with paclitaxel in patients with stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer who had initial debulking surgery.
2. Determine the feasibility of this regimen in these patients.

Secondary

1. Determine the toxicity profile of this regimen in these patients.
2. Determine the response rate (in patients with measurable disease who are in the expanded cohort) and progression-free survival of patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
  • Stage II-IV disease



• The following histologic epithelial cell types are eligible:
  • Serous adenocarcinoma
  • Mucinous adenocarcinoma
  • Clear cell adenocarcinoma
  • Transitional cell carcinoma
  • Adenocarcinoma not otherwise specified
  • Endometrioid adenocarcinoma
  • Undifferentiated carcinoma
  • Mixed epithelial carcinoma
  • Malignant Brenner's tumor



• Optimal (≤ 1 cm residual disease) OR suboptimal residual disease after initial debulking surgery (performed within the past 12 weeks)



• Synchronous primary endometrial cancer OR prior history of endometrial cancer allowed provided all of the following are true:
  • Stage IB disease or less
  • Less than 3 mm invasion without vascular or lymphatic invasion
  • No poorly differentiated subtypes, including the following:
    • Papillary serous
    • Clear cell
    • Other FIGO grade 3 lesions



• No epithelial tumors of low malignant potential (borderline tumors)

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• At least 3 years since prior adjuvant chemotherapy for localized breast cancer
  • Patients must remain free of recurrent or metastatic disease

Endocrine therapy

• Not specified

Radiotherapy

• At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin
  • Patient must remain free of recurrent or metastatic disease
• No prior radiotherapy to any portion of the abdominal cavity or pelvis

Surgery

• See Disease Characteristics

Other

• No prior therapy for this malignancy
• No prior cancer treatment that contraindicates study therapy
• No concurrent amifostine or other protective agents

Patient Characteristics:

Age

• 18 and over

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• No active bleeding

Hepatic

• AST ≤ 3 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 3 times ULN
• Bilirubin ≤ 1.5 times ULN
• No acute hepatitis

Renal

• Creatinine ≤ 2.0 mg/dL

Cardiovascular

• No unstable angina
• No myocardial infarction within the past 6 months
• Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided the patient's cardiac status has been stable for at least 6 months before study entry

Other

• No neuropathy (sensory and motor) > grade 1
• No active infection requiring antibiotics
• No circumstances that would preclude study participation
• No other invasive malignancies within the past 5 years except non-melanoma skin cancer or localized breast cancer

Expected Enrollment

A total of 3-64 patients (3-24 for dose escalation and 20-40 for feasibility) will be accrued for this study within 15 months.

Outcomes

Maximum tolerated dose of intraperitoneal carboplatin when administered with paclitaxel
Feasibility of treatment

Toxicity profile
Response rate (in patients with measurable disease who are in the expanded cohort) and progression-free survival

Outline

This is a multicenter, dose-escalation study of intraperitoneal carboplatin.

Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 20-40 patients are treated at that dose level.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Mark Morgan, MD, FACOG, FACS, Protocol chair		Ph: 215-214-1430; 888-369-2427 Email: mark.morgan@fccc.edu

U.S.A.
California
	Orange
	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
		Clinical Trials Office - Chao Family Comprehensive Cancer Center	Ph:  877-UC-STUDY
			Email: ucstudy@uci.edu
Illinois
	Chicago
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins	Ph:  410-955-8804
			Email: jhcccro@jhmi.edu
New Jersey
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees	Ph:  856-325-6757
Ohio
	Cleveland
	Case Comprehensive Cancer Center
		Clinical Trials Office - Case Comprehensive Cancer Center	Ph:  800-641-2422
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
	Columbus
	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
		Clinical Trials Office - OSU Comprehensive Cancer Center	Ph:  614-293-4976
			Email: osu@emergingmed.com
	Riverside Methodist Hospital Cancer Care
		Clinical Trials Office - Riverside Methodist Hospital Cancer Care	Ph:  614-566-4475
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Robert Mannel, MD	Ph:  405-271-8787
Pennsylvania
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Clinical Trials Office - Abramson Cancer Center of the University of Pennsylvania	Ph:  800-474-9892
	Fox Chase Cancer Center - Philadelphia
		Clinical Trials Office - Fox Chase Cancer Center - Philadelphia	Ph:  215-728-4790
Rhode Island
	Providence
	Women and Infants Hospital of Rhode Island
		Clinical Trials Office - Women and Infants Hospital of Rhode Island	Ph:  401-274-1122
Washington
	Seattle
	Fred Hutchinson Cancer Research Center
		Benjamin Greer, MD	Ph:  206-685-2463
	University Cancer Center at University of Washington Medical Center
		Clinical Trials Office - University Cancer Center at University of Washington Medical Center	Ph:  206-616-8289
Japan
	Saitama
	Saitama Medical University International Medical Center
		Keiichi Fujiwara, MD, PhD	Ph:  81-42-984-4637

Registry Information
Official Title		A Dose Escalating Phase I Study With An Expanded Cohort To Assess The Feasibility Of Intraperitoneal Carboplatin (NSC #214240) And Intravenous Paclitaxel (NSC # 673089) In Patients With Previously Untreated Epithelial Ovarian, Primary Peritoneal, Or Fallopian Tube Carcinoma
Trial Start Date		2004-06-03
Trial Completion Date		2005-07-08 (estimated)
Registered in ClinicalTrials.gov		NCT00079430
Date Submitted to PDQ		2004-02-05
Information Last Verified		2009-01-07
NCI Grant/Contract Number		CA27469

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