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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003322
First Posted: May 21, 2004
Last Update Posted: May 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether intravenous two-drug combination chemotherapy is more effective than intravenous and intraperitoneal infusions of three-drug combination chemotherapy for treating primary peritoneal or stage III epithelial ovarian cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous two-drug combination chemotherapy with intravenous and intraperitoneal three-drug combination chemotherapy in treating patients who have primary peritoneal or stage III epithelial ovarian cancer.


Condition Intervention Phase
Ovarian Cancer Primary Peritoneal Cavity Cancer Drug: cisplatin Drug: paclitaxel Procedure: quality-of-life assessment Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Estimated Enrollment: 384
Study Start Date: March 1998
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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.

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.

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

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

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003322


  Show 67 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Deborah K. Armstrong, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Publications:
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, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43.
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, Armstrong D, Baysal BE, Gallion H, Ambrosone CB, DeLoia JA; Gynecologic Oncology Group Phase III Trial. 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. 2008 Jul 20;26(21):3598-606. doi: 10.1200/JCO.2008.16.1323.
Krivak TC, Tian C, Rose GS, Armstrong DK, Maxwell GL. A Gynecologic Oncology Group Study of serum CA-125 levels in patients with stage III optimally debulked ovarian cancer treated with intraperitoneal compared to intravenous chemotherapy: an analysis of patients enrolled in GOG 172. Gynecol Oncol. 2009 Oct;115(1):81-5. doi: 10.1016/j.ygyno.2009.06.021. Epub 2009 Jul 12.
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, Kapali M, Armstrong DK, DeLoia JA. BRCA1 expression in a large series of sporadic ovarian carcinomas: a Gynecologic Oncology Group study. Int J Gynecol Cancer. 2006 Jan-Feb;16 Suppl 1:166-71.
von Gruenigen VE, Huang HQ, Gil KM, Frasure HE, Armstrong DK, Wenzel LB. The association between quality of life domains and overall survival in ovarian cancer patients during adjuvant chemotherapy: a Gynecologic Oncology Group Study. Gynecol Oncol. 2012 Mar;124(3):379-82. doi: 10.1016/j.ygyno.2011.11.032. Epub 2011 Nov 23.
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, Fowler J, Webster K, Burger RA, Clarke-Pearson D. 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. 2006 Jan;100(1):27-32.
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, Walker JL, Cella D; Gynecologic Oncology Group. 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. 2007 Feb 1;25(4):437-43.
Wenzel L, Huang HQ, Cella D, Walker JL, Armstrong DK; Gynecologic Oncology Group. Validation of FACT/GOG-AD subscale for ovarian cancer-related abdominal discomfort: a Gynecologic Oncology Group study. Gynecol Oncol. 2008 Jul;110(1):60-4. doi: 10.1016/j.ygyno.2008.02.011. Epub 2008 Apr 21.
Barlin JN, Dao F, Bou Zgheib N, Ferguson SE, Sabbatini PJ, Hensley ML, Bell-McGuinn KM, Konner J, Tew WP, Aghajanian C, Chi DS. Progression-free and overall survival of a modified outpatient regimen of primary intravenous/intraperitoneal paclitaxel and intraperitoneal cisplatin in ovarian, fallopian tube, and primary peritoneal cancer. Gynecol Oncol. 2012 Jun;125(3):621-4. doi: 10.1016/j.ygyno.2012.03.027. Epub 2012 Mar 21.
Rubatt JM, Darcy KM, Tian C, Muggia F, Dhir R, Armstrong DK, Bookman MA, Niedernhofer LJ, Deloia J, Birrer M, Krivak TC. Pre-treatment tumor expression of ERCC1 in women with advanced stage epithelial ovarian cancer is not predictive of clinical outcomes: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 May;125(2):421-6. doi: 10.1016/j.ygyno.2012.01.008. Epub 2012 Jan 16.
Tian C, Ambrosone CB, Darcy KM, Krivak TC, Armstrong DK, Bookman MA, Davis W, Zhao H, Moysich K, Gallion H, DeLoia JA. Common variants in ABCB1, ABCC2 and ABCG2 genes and clinical outcomes among women with advanced stage ovarian cancer treated with platinum and taxane-based chemotherapy: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 Mar;124(3):575-81. doi: 10.1016/j.ygyno.2011.11.022. Epub 2011 Nov 21.
Hamilton CA, Miller A, Miller C, Krivak TC, Farley JH, Chernofsky MR, Stany MP, Rose GS, Markman M, Ozols RF, Armstrong DK, Maxwell GL. The impact of disease distribution on survival in patients with stage III epithelial ovarian cancer cytoreduced to microscopic residual: a Gynecologic Oncology Group study. Gynecol Oncol. 2011 Sep;122(3):521-6. doi: 10.1016/j.ygyno.2011.04.041. Epub 2011 Jun 17.
Aletti GD, Nordquist D, Hartmann L, Gallenberg M, Long HJ, Cliby WA. From randomized trial to practice: single institution experience using the GOG 172 i.p. chemotherapy regimen for ovarian cancer. Ann Oncol. 2010 Sep;21(9):1772-8. doi: 10.1093/annonc/mdq025. Epub 2010 Feb 5.
von Gruenigen VE, Huang HQ, Gil KM, Gibbons HE, Monk BJ, Rose PG, Armstrong DK, Cella D, Wenzel L. A comparison of quality-of-life domains and clinical factors in ovarian cancer patients: a Gynecologic Oncology Group study. J Pain Symptom Manage. 2010 May;39(5):839-46. doi: 10.1016/j.jpainsymman.2009.09.022.
Darcy KM, Tian C, Ambrosone CB, et al.: A Gynecologic Oncology Group study of associations between polymorphisms in ABC transporter genes (ABCB1, ABCC2, and ABCG2) and outcome in advanced stage epithelial ovarian cancer treated with platinum and taxane chemotherapy. [Abstract] J Clin Oncol 27 (Suppl 15): A-5567, 2009.
Farley JH, Tian C, Rose GS, Brown CL, Birrer M, Maxwell GL. Race does not impact outcome for advanced ovarian cancer patients treated with cisplatin/paclitaxel: an analysis of Gynecologic Oncology Group trials. Cancer. 2009 Sep 15;115(18):4210-7. doi: 10.1002/cncr.24482.
Zorn KK, Tian C, McGuire WP, Hoskins WJ, Markman M, Muggia FM, Rose PG, Ozols RF, Spriggs D, Armstrong DK. The prognostic value of pretreatment CA 125 in patients with advanced ovarian carcinoma: a Gynecologic Oncology Group study. Cancer. 2009 Mar 1;115(5):1028-35. doi: 10.1002/cncr.24084.
Havrilesky LJ, Secord AA, Darcy KM, Armstrong DK, Kulasingam S; Gynecologic Oncology Group. 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. 2008 Sep 1;26(25):4144-50. doi: 10.1200/JCO.2007.13.1961.
Bristow RE, Santillan A, Salani R, Diaz-Montes TP, Giuntoli RL 2nd, Meisner BC, Armstrong DK, Frick KD. Intraperitoneal cisplatin and paclitaxel versus intravenous carboplatin and paclitaxel chemotherapy for Stage III ovarian cancer: a cost-effectiveness analysis. Gynecol Oncol. 2007 Sep;106(3):476-81. Epub 2007 Aug 3.
Winter WE 3rd, Maxwell GL, Tian C, Carlson JW, Ozols RF, Rose PG, Markman M, Armstrong DK, Muggia F, McGuire WP; Gynecologic Oncology Group Study. Prognostic factors for stage III epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Aug 20;25(24):3621-7.
Alberts DS, Delforge A. Maximizing the delivery of intraperitoneal therapy while minimizing drug toxicity and maintaining quality of life. Semin Oncol. 2006 Dec;33(6 Suppl 12):S8-17. Review.
Armstrong DK, Brady MF. Intraperitoneal therapy for ovarian cancer: a treatment ready for prime time. J Clin Oncol. 2006 Oct 1;24(28):4531-3.
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. 2006 Dec;33(6 Suppl 12):S3-7. Review.
Singhal P, Lele S. Intraperitoneal chemotherapy for ovarian cancer: where are we now? J Natl Compr Canc Netw. 2006 Oct;4(9):941-6. Review.
Baysal BE, DeLoia JA, Willett-Brozick JE, Goodman MT, Brady MF, Modugno F, Lynch HT, Conley YP, Watson P, Gallion HH. Analysis of CHEK2 gene for ovarian cancer susceptibility. Gynecol Oncol. 2004 Oct;95(1):62-9.

ClinicalTrials.gov Identifier: NCT00003322     History of Changes
Other Study ID Numbers: CDR0000066273
GOG-0172
First Submitted: November 1, 1999
First Posted: May 21, 2004
Last Update Posted: May 27, 2013
Last Verified: August 2012

Keywords provided by Gynecologic Oncology Group:
stage III ovarian epithelial cancer
recurrent ovarian epithelial cancer
ovarian undifferentiated adenocarcinoma
ovarian mixed epithelial carcinoma
ovarian serous cystadenocarcinoma
ovarian mucinous cystadenocarcinoma
ovarian endometrioid adenocarcinoma
ovarian clear cell cystadenocarcinoma
primary peritoneal cavity cancer
Brenner tumor

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
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
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action


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