H. Lee Moffitt Cancer Center & Research Institute

Clinical Research Protocols

CLINICAL RESEARCH PROTOCOLS FOR OVARIAN AND OTHER GYNECOLOGIC CANCERS


This list of clinical research protocols relating to ovarian
and other gynecologic cancers is compiled for your convenience.

High Priority

GOG-137A, E-G137 NCI HIGH PRIORITY CLINICAL TRIAL Phase III Study of Estrogen Replacement Therapy vs Placebo in Women With Stage I or II Endometrial Adenocarcinoma

Chairperson: Richard R. Barakat. Telephone: 212-639-2453. Lead organization: Gynecologic Oncology Group. Age range: not specified.

GOG-164, E-G0164 NCI HIGH PRIORITY CLINICAL TRIAL Phase III Randomized Study of Salvage Therapy With Paclitaxel/Carboplatin vs Stem Cell Supported High-DoseCarboplatin/Mitoxantrone/Cyclophosphamide in Persistent Low-Volume Ovarian Epithelial Cancer

Chairperson: William McGuire, III. Telephone: 404-321-0111. Lead organization: Gynecologic Oncology Group. Age range: under 66.

Phase III Cervical Cancer

MDA-ID-92027, NCI-P97-0092 Phase III Randomized, Double Blinded, Placebo Controlled Study of Fenretinide in Patients With Cervical Intraepithelial Neoplasia (CIN) Grade 2-3

Chairperson: Michele Follen Mitchell. Telephone: 713-745-2564. Lead organization: University of Texas - MD Anderson Cancer Center. Age range: 18 and over.

DUT-KWF-CKVO-9407, EU-95013 Phase III Randomized Study of CBDCA/5-FU With Pelvic Radiotherapy vs Radiotherapy Alone for Locally Advanced Cervical Cancer

Chairperson: E. Pras. Telephone: +31-50-3613674 (Netherlands). Lead organization: Academisch Ziekenhuis Groningen. Age range: 75 and under.

GOG-141 Phase III Study in the Treatment of Bulky Stage IB Carcinoma of the Cervix: Neoadjuvant CDDP/VCR vs No Neoadjuvant Therapy Followed by Radical Hysterectomy and Pelvic/Para-aortic Node Dissection

Chairperson: Gary Lee Eddy. Telephone: 715-389-3101. Lead organization: Gynecologic Oncology Group. Age range: no age specified.

EORTC-55954, COSA, EU-98061, NSGO-CC-9502, MRC-CE04 Phase III Study of Radiotherapy With or Without Chemotherapy as Adjuvant Treatment for Patients With Node Positive Stage IB or IIA Cervical Cancer

Chairperson: Jan Baptist Vermorken. Telephone: +32-3-821-3954 (Belgium). Lead organization: EORTC Gynecological Cancer Cooperative Group. Age range: 18 and over.

GOG-169 Phase III Randomized Study of Cisplatin (CDDP) vs Cisplatin Plus Paclitaxel (Taxol) in Recurrent, Refractory, or Stage IVB Squamous Cell Carcinoma of the Cervix

Chairperson: David Harry Moore. Telephone: 317-274-2422. Lead organization: Gynecologic Oncology Group. Age range: not specified.

GOG-165 Phase III Randomized Comparison Study of Radiotherapy Plus Cisplatin vs Radiotherapy Plus Fluorouracil in Patients With Uterine Cervix Carcinoma

Chairperson: Rachelle M. Lanciano. Telephone: 610-284-8240. Lead organization: Gynecologic Oncology Group. Age range: any age.

Phase III Ovarian Epithelial Cancer

MRC-OV06, EU-98063 Phase III Randomized Study of Chemotherapy With or Without Interval Debulking Surgery in Patients With Stage II or III Ovarian Epithelial Cancer Suboptimally Debulked at Primary Surgery

Chairperson: Julia Bland. Telephone: +44-0-1223-311110 (United Kingdom). Lead organization: United Kingdom Medical Research Council. Age range: not specified.

GOG-175 Phase III Randomized Study of Carboplatin and Paclitaxel With or Without Low-Dose Paclitaxel in Patients With Early-Stage Ovarian Carcinoma

Chairperson: Robert C. Park. Telephone: 215-854-0770. Lead organization: Gynecologic Oncology Group. Age range: not specified.

MRC-ICON4, EU-96051 Phase III Randomized Study of Paclitaxel With Either Carboplatin or Cisplatin vs Conventional Platinum-Based Chemotherapy in Relapsed Ovarian Cancer

Chairperson: J. A. Ledermann. Telephone: +44-171-504-9430 (United Kingdom). Lead organization: United Kingdom Medical Research Council. Age range: no age specified.

MRC-ICON1, EU-91002 Phase III Randomized Study of Adjuvant Therapy With a Platinum-Containing Regimen (eg, CBDCA or CAP: CTX/DOX/CDDP) vs No Adjuvant Therapy in Patients With Fully Resected Early-Stage Ovarian Cancer

Chairperson: Christopher J. Williams. Telephone: +44-186-522-6628 (United Kingdom). Lead organization: United Kingdom Medical Research Council. Age range: any age.

SEQUUS-30-49, NCI-V97-1257 Phase III Randomized, Open-Label, Comparative Study of Liposomal Doxorubicin (DOXIL) vs Topotecan HCl in Patients With Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy

Chairperson: Kenneth Cunningham. Telephone: 650-617-3062. Lead organization: SEQUUS Pharmaceuticals, Inc. Age range: 18 and over.

MRC-OV05, EU-96050, EORTC-55955 Phase III Randomized Study of the Benefit of Early Chemotherapy Based on CA 125 Level Alone vs Delayed Chemotherapy Based on Conventional Clinical Indicators for Relapsed Ovarian Cancer

Chairperson: David Guthrie. Telephone: +01332-347141, ext 4574 (United Kingdom). Lead organization: United Kingdom Medical Research Council. Age range: no age specified.

EORTC-55971 Phase III Randomized Study of Neoadjuvant Chemotherapy Followed by Interval Debulking Surgery vs Upfront Cytoreductive Surgery Followed by Chemotherapy With or Without Interval Debulking Surgery in Patients With Stage IIIC or IV Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer

Chairperson: Ignace B. Vergote. Telephone: +016-344635 (Belgium). Lead organization: EORTC Gynecological Cancer Cooperative Group. Age range: not specified.

ANTHRA-A9503 Phase III Randomized Study of Intraperitoneal AD 32 vs Oral Altretamine in Patients With Refractory or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma Who Have Failed Platinum and Paclitaxel Chemotherapy

Chairperson: Maurie Markman. Telephone: 216-445-6888. Lead organization: Anthra Pharmaceuticals, Inc. Age range: 18 and over.

EORTC-55904 Phase III Randomized Comparison of Adjuvant Platinum-Containing Chemotherapy (CDDP or CBDCA With or Without Other Agents) vs No Adjuvant Therapy in Patients With Stage I/II Ovarian Epithelial Carcinoma

Chairperson: J. Baptist Trimbos. Telephone: +31-71-526 2845 (Belgium). Lead organization: EORTC Gynecological Cancer Cooperative Group. Age range: any age.

SWOG-9701 Phase III Randomized Trial of 12 Months vs 3 Months of Paclitaxel in Patients With Advanced Ovarian Cancer in Complete Remission Following Platinum/Paclitaxel Based-Chemotherapy

Chairperson: Maurie Markman. Telephone: 216-445-6888. Lead organization: Southwest Oncology Group. Age range: over 65 at registration.

GOG-162 Phase III Randomized Study of 24- vs 96-Hour Infusion of TAX With CDDP for Suboptimal Stage III/IV Ovarian Epithelial Cancer

Chairperson: David R. Spriggs. Telephone: 212-639-2203. Lead organization: Gynecologic Oncology Group. Age range: 18 and over.

GOG-152 Phase III Randomized Study of Paclitaxel (Taxol) and Cisplatin (CDDP) Alone vs Taxol/CDDP With Interval Secondary Cytoreductive Surgery for Suboptimally Resected Stage III Ovarian Epithelial Carcinoma

Chairperson: Peter Graham Rose. Telephone: 216-844-5011. Lead organization: Gynecologic Oncology Group. Age range: any age.

GOG-172 Phase III Randomized Study of Intravenous (IV) Paclitaxel and Cisplatin vs IV Paclitaxel, Intraperitoneal (IP) Cisplatin, and IP Paclitaxel in Patients With Optimal Stage III Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma

Chairperson: Deborah K. Armstrong. Telephone: 410-614-2743. Lead organization: Gynecologic Oncology Group Age range: not specified.

SWOG-8790, INT-0083, GOG-133 Phase III Randomized Comparison of Adjuvant Intraperitoneal Interferon alpha vs No Further Treatment in Patients With Stage III Ovarian Carcinoma With No Evidence of Disease at Second-Look Laparotomy Following Platinum-Based Chemotherapy

Chairperson: Edward V. Hannigan. Telephone: 409-772-2368. Lead organization: Southwest Oncology Group. Age range: 18 and over.

Legend for Abbreviations:

ANTHRA = Anthra Pharmaceuticals, Inc.

COSA = Clinical Oncology Society of Australia

DUT-KWF = Koningin Wilhelmina Fonds (Holland)

E = Eastern Cooperative Oncology Group

EORTC = European Organization for Research on Treatment of Cancer

EU = European Voluntary Protocol

GOG = Gynecologic Oncology Group

MDA = MD Anderson Cancer Center

MRC = UK Medical Research Council

NCI = National Cancer Institute

SEQUUS = SEQUUS Pharmaceuticals, Inc.

SWOG = Southwest Oncology Group



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