Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Paclitaxel and Cisplatin in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	18 and over	NCI	GOG-0162 NCT00002717, GOG-0162

Objectives

I.  Compare progression free and overall survival and frequency of response in 
patients with suboptimal stage III or IV ovarian epithelial cancer or primary 
peritoneal cancer treated with a 24 hour vs 96 hour infusion of paclitaxel 
(TAX) followed by cisplatin.

II.  Determine the incidence and severity of adverse events, including 
catheter complications and drug toxicity, for the 96 hour infusion of TAX.

III.  Compare the relationship between plasma TAX concentrations, toxicity,  
and response to both infusion schedules in this patient population.

Entry Criteria

Disease Characteristics:

Histologically confirmed primary ovarian epithelial cancer or primary
peritoneal cancer

Suboptimal residual disease within 6 weeks of laparotomy with maximum
resection

Stage III residual retroperitoneal disease greater than 1 cm and no greater
than 1 cm residual intraperitoneal disease 

OR

Stage IV disease

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

Measurable disease not required
 Cytologic confirmation of malignant pleural effusion required if sole basis
  of entry

No borderline (low malignant potential) carcinoma

No unclassified ovarian cancer, i.e., thought to be of ovarian origin but
unexplored or unable to verify tumor arising from ovarian stroma

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No prior cytotoxic chemotherapy 

Endocrine therapy:
 Not specified
Radiotherapy:
 No prior radiotherapy

Surgery:
 See Disease Characteristics
 No more than 6 weeks since staging laparotomy and primary cytoreductive
  surgery

Patient Characteristics:

Age:
 18 and over

Performance status:
 GOG 0-2

Hematopoietic:
 WBC at least 3,000/mm3
 Absolute granulocyte count at least 1,500/mm3
 Platelet count at least 100,000/mm3

Hepatic:
 Bilirubin no greater than 1.5 times normal
 AST, ALT, and GGT no greater than 3 times normal
 Alkaline phosphatase no greater than 3 times normal
 LDH no greater than 3 times normal
 No acute hepatitis

Renal:
 Creatinine no greater than 2 mg/dL

Cardiovascular:
 No history of congestive heart failure
 No history of unstable angina
 No myocardial infarction within 6 months

Other:
 No severe infection, including septicemia
 No severe gastrointestinal bleeding
 No history of second malignancy within 5 years except nonmelanomatous skin
  cancer
 Not pregnant or nursing
 Fertile patients must use effective contraception

Expected Enrollment

A total of 324 patients will be accrued for this study over 4.5 years.

Outline

This is a randomized, multicenter study. Patients are stratified according to 
participating center and measurable disease (yes vs no). Patients are 
randomized into one of two treatment arms.

Arm I: Patients receive paclitaxel IV continuously over 24 hours followed by 
cisplatin IV over 2 hours.

Arm II: Patients receive paclitaxel IV continuously over 96 hours followed by 
cisplatin IV over 2 hours.

Treatment repeats every 3 weeks for 6 courses.

Spriggs DR, Brady MF, Vaccarello L, et al.: Phase III randomized trial of intravenous cisplatin plus a 24- or 96-hour infusion of paclitaxel in epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol 25 (28): 4466-71, 2007.[PUBMED Abstract]

Spriggs DR, Brady M, Rubin S, et al.: A phase III randomized trial of cisplatin and paclitaxel administered by either 24 hour or 96 hour infusion in patients with selected stage III or stage IV epithelial ovarian cancer (GOG162). [Abstract] J Clin Oncol 22 (Suppl 14): A-5004, 450s, 2004.

Zorn KK, Tian C, McGuire WP, et al.: The prognostic value of pretreatment CA 125 in patients with advanced ovarian carcinoma: a Gynecologic Oncology Group study. Cancer 115 (5): 1028-35, 2009.[PUBMED Abstract]

Winter WE 3rd, Maxwell GL, Tian C, et al.: Tumor residual after surgical cytoreduction in prediction of clinical outcome in stage IV epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol 26 (1): 83-9, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

David R. Spriggs, MD, Protocol chair		Ph: 212-639-2203; 800-525-2225

Registry Information
Official Title		A Phase III Randomized Trial of Cisplatin (NSC #119875) with Paclitaxel (NSC #125973) Administered by Either 24 Hour Infusion or 96 Hour Infusion in Patients with Selected Stage III and Stage IV Epithelial Ovarian Cancer and Primary Peritoneal Carcinoma
Trial Start Date		1996-03-25
Trial Completion Date		2007-10-01
Registered in ClinicalTrials.gov		NCT00002717
Date Submitted to PDQ		1996-03-25
Information Last Verified		2009-05-05
NCI Grant/Contract Number		U10-CA27469