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

Alternate Title

Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care, Treatment Closed Not specified NCI GOG-172 NCT00003322, GOG-0172

Objectives

I.   Compare pathological response, recurrence-free interval, and survival in 
patients with optimal stage III epithelial ovarian cancer or primary 
peritoneal carcinoma receiving intravenous (IV) paclitaxel and cisplatin vs IV 
paclitaxel and intraperitoneal (IP) cisplatin plus IP paclitaxel.

II.  Compare the toxic effects and complications of these 2 treatment regimens 
in these patients.

III. Determine the frequency and prognostic significance of BRCA1 and BRCA2 
mutations in these patients.

IV.  Determine the effect of non-genetic risk factors on the course of disease 
in BRCA1- and BRCA2-related ovarian cancer or primary peritoneal carcinoma.

V.   Compare the quality of life of these patients receiving these treatments.

Entry Criteria

Disease Characteristics:

Histologically proven primary peritoneal carcinoma or optimal (no greater than
1 cm residual disease) stage III epithelial ovarian carcinoma with the
following epithelial cell types:
    Serous adenocarcinoma               Endometrioid adenocarcinoma
    Mucinous adenocarcinoma             Undifferentiated carcinoma
    Clear cell adenocarcinoma           Mixed epithelial carcinoma
    Transitional cell carcinoma         Malignant Brenner's Tumor
    Adenocarcinoma NOS

Prior surgery for ovarian/peritoneal carcinoma required

No epithelial ovarian carcinoma of low malignant potential (borderline
carcinoma)

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No prior chemotherapy

Endocrine therapy:
 Not specified

Radiotherapy:
 No prior radiotherapy

Surgery:
 See Disease Characteristics
 No more than 6 weeks since prior surgery

Patient Characteristics:

Age:
 Not specified

Performance status:
 GOG 0-2

Life expectancy:
 Not specified

Hematopoietic:
 WBC at least 3,000/mm3
 Platelet count at least 100,000/mm3

Hepatic:
 Bilirubin no greater than 1.5 times normal
 SGOT no greater than 3 times normal
 Alkaline phosphatase no greater than 3 times normal
 No acute hepatitis

Renal:
 Creatinine no greater than 2.0 mg/dL

Cardiovascular:
 No unstable angina 
 No myocardial infarction within prior 6 months
 Patients with abnormal cardiac conduction are eligible if disease stable for
  at least 6 months

Other:
 No septicemia or severe infection
 No severe gastrointestinal bleeding 
 No other invasive malignancy within past 5 years except nonmelanoma skin
  cancer 
 Any previous cancer treatment must not contraindicate this protocol therapy

Expected Enrollment

Approximately 384 patients will be accrued for this study within 16 months.

Outline

This is a randomized study.  Patients are stratified according to gross 
residual disease (present vs absent) and whether second-look surgery will be 
performed at the end of treatment (yes vs no).

Blood is drawn for BRCA mutation analysis and DNA extraction before the start 
of chemotherapy, but after randomization.  Patients are randomized to one of 
two treatment arms.  Patients in arm I receive IV paclitaxel by 24-hour 
infusion on day 1 followed by IV cisplatin on day 2.  Patients in arm II 
receive IV paclitaxel by 24-hour infusion on day 1 followed by intraperitoneal 
(IP) cisplatin on day 2, plus IP paclitaxel on day 8.  Treatment for both arms 
repeats every 3 weeks for a total of 6 treatment courses.  Following 
chemotherapy, second look surgery is performed if selected by the patient.

Quality-of-life assessments are performed prior to randomization, prior to 
course 4, 3-6 weeks after the completion of course 6 and prior to second look 
surgery if selected, 6 months after treatment is completed, and 12 months 
after treatment is completed.

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

Armstrong DK, Bundy BN, Baergen R, et al.: Randomized phase III study of intravenous (IV) paclitaxel and cisplatin versus IV paclitaxel, intraperitoneal (IP) cisplatin and IP paclitaxel in optimal stage III epithelial ovarian cancer (OC): a Gynecologic Oncology Group trial (GOG 172). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-803, 2002.

Armstrong DK, Bundy B, Wenzel L, et al.: Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med 354 (1): 34-43, 2006.[PUBMED Abstract]

DeLoia JA, Krivak T, Darcy KM, et al.: Relationship between the C8092A polymorphisms in ERCC1 and clinical outcome in optimally-resected, stage III epithelial ovarian cancer treated with intraperitoneal or intravenous cisplatin and paclitaxel: a Gynecologic Oncology Group study. [Abstract] American Association for Cancer Research: 98th Annual Meeting, April 14-18, 2007, Los Angeles, CA. A-1674, 2007.

Krivak TC, Darcy KM, Tian C, et al.: Relationship between polymorphisms in cordon 118 and C8092A in ERCC1 and clinical outcome in optimally-resected, stage III epithelial ovarian cancer treated with intraperitoneal or intravenous cisplatin and paclitaxel: a Gynecologic Oncology Group study. [Abstract] J Clin Oncol 25 (Suppl 18): A-21050, 733s, 2007.

Krivak TC, Darcy KM, Tian C, et al.: Relationship between ERCC1 polymorphisms, disease progression, and survival in the Gynecologic Oncology Group Phase III Trial of intraperitoneal versus intravenous cisplatin and paclitaxel for stage III epithelial ovarian cancer. J Clin Oncol 26 (21): 3598-606, 2008.[PUBMED Abstract]

Krivak T, Darcy K, Tian C, et al.: Relationship between polymorphisms in ERCC1 and clinical outcome in optimally resected stage III epithelial ovarian cancer: a Gynecologic Oncology Group study. [Abstract] Society of Gynecologic Oncologists, 2007 Annual Meeting on Women's Cancer, March 3-7, 2007, San Diego, CA. A-146, 2007.

Seamon LG, Carlson MJ, Richardson DL, et al.: Improved intraperitoneal chemotherapeutic toxicity profile for ovarian cancer: A modification of the taxane-platinum protocol in GOG-172. [Abstract] J Clin Oncol 26 (Suppl 15): A-5583, 2008.

Thrall M, Gallion HH, Kryscio R, et al.: BRCA1 expression in a large series of sporadic ovarian carcinomas: a Gynecologic Oncology Group study. Int J Gynecol Cancer 16 (Suppl 1): 166-71, 2006 Jan-Feb.[PUBMED Abstract]

Walker JL, Armstrong D, Huang H, et al.: Intraperitoneal catheter outcomes on GOG 172: a Gynecologic Oncology Group study in women with optimally debulked stage III ovarian cancer. [Abstract] Int J Gynecol Cancer 14 (Suppl 1): A-062, 19, 2004.

Walker JL, Armstrong DK, Huang HQ, et al.: Intraperitoneal catheter outcomes in a phase III trial of intravenous versus intraperitoneal chemotherapy in optimal stage III ovarian and primary peritoneal cancer: a Gynecologic Oncology Group Study. Gynecol Oncol 100 (1): 27-32, 2006.[PUBMED Abstract]

Wenzel LB, Huang HQ, Armstrong DK, et al.: Baseline quality of life (QOL) as a predictor of tolerance to intraperitoneal (IP) chemotherapy for advanced epithelial ovarian cancer (EOC): a Gynecologic Oncology Group (GOG) study. [Abstract] J Clin Oncol 24 (Suppl 18): A-5007, 257s, 2006.

Wenzel LB, Huang HQ, Armstrong DK, et al.: Health-related quality of life during and after intraperitoneal versus intravenous chemotherapy for optimally debulked ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol 25 (4): 437-43, 2007.[PUBMED Abstract]

Wenzel L, Huang HQ, Cella D, et al.: Validation of FACT/GOG-AD subscale for ovarian cancer-related abdominal discomfort: a Gynecologic Oncology Group study. Gynecol Oncol 110 (1): 60-4, 2008.[PUBMED Abstract]

Havrilesky LJ, Secord AA, Darcy KM, et al.: Cost effectiveness of intraperitoneal compared with intravenous chemotherapy for women with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol 26 (25): 4144-50, 2008.[PUBMED Abstract]

Bristow RE, Santillan A, Salani R, et al.: Intraperitoneal cisplatin and paclitaxel versus intravenous carboplatin and paclitaxel chemotherapy for Stage III ovarian cancer: a cost-effectiveness analysis. Gynecol Oncol 106 (3): 476-81, 2007.[PUBMED Abstract]

Winter WE 3rd, Maxwell GL, Tian C, et al.: Prognostic factors for stage III epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol 25 (24): 3621-7, 2007.[PUBMED Abstract]

Alberts DS, Delforge A: Maximizing the delivery of intraperitoneal therapy while minimizing drug toxicity and maintaining quality of life. Semin Oncol 33 (6 Suppl 12): S8-17, 2006.[PUBMED Abstract]

Armstrong DK, Brady MF: Intraperitoneal therapy for ovarian cancer: a treatment ready for prime time. J Clin Oncol 24 (28): 4531-3, 2006.[PUBMED Abstract]

Markman M: Clinical efficacy supporting the role of intraperitoneal drug delivery in the primary chemotherapeutic management of small-volume residual advanced ovarian cancer. Semin Oncol 33 (6 Suppl 12): S3-7, 2006.[PUBMED Abstract]

Singhal P, Lele S: Intraperitoneal chemotherapy for ovarian cancer: where are we now? J Natl Compr Canc Netw 4 (9): 941-6, 2006.[PUBMED Abstract]

Baysal BE, DeLoia JA, Willett-Brozick JE, et al.: Analysis of CHEK2 gene for ovarian cancer susceptibility. Gynecol Oncol 95 (1): 62-9, 2004.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Deborah Armstrong, MD, Protocol chair		Ph: 410-614-2743 Email: darmstro@jhmi.edu

Registry Information
Official Title		A Phase III Randomized Trial of Intravenous Paclitaxel and Cisplatin Versus Intravenous Paclitaxel, Intraperitoneal Cisplatin and Intraperitoneal Paclitaxel in Patients with Optimal Stage III Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma
Trial Start Date		1998-03-23
Registered in ClinicalTrials.gov		NCT00003322
Date Submitted to PDQ		1998-05-08
Information Last Verified		2008-09-23
NCI Grant/Contract Number		CA27469