MDACC Study Summary GOG 0182

Study Summary
No. GOG 0182:.......Ovary; Gynecology......John J. Kavanagh......Gynecologic Medical Oncology

Study Summary Title



Study Summary Number:	GOG 0182

Study Title:	A Phase III Randomized Trial of Paclitaxel and Carboplatin versus Triplet or Sequential Doublet Combinations in Patients with Epithelial Ovarian or Primary Peritoneal Cancer

Physician

New Patient Referral



Name:	John J. Kavanagh	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gynecologic Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-7959 Contact us about clinical trials

General Information



Disease Group:	Ovary Gynecology	Supported By:	Gynecologic Oncology Group

Phase of Study:	Phase III	Return Visit:	For treatment: (dependent on regimen in which the patient is enrolled) arms 1,2,& 3; 1 or 2 days every 21 days X 8 courses; arms 4&5: 2 days every 21 days X 8 courses; follow-up: every 3 months for 24 months then every 6 months thereafter.

Treatment Agents:	Treatment information not available	Home Care:	None

Treatment Loc:	both inpatient and outpatient

Estimated Length of Stay in Houston:	If primary surgery is done here; 5-7 days


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

Unavailable

Study Status Information



Study Activation / Registration Date:	01/17/2003

IRB Review and Approval Date:	12/18/2002

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	40

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

Patients with a histologic diagnosis of primary peritoneal carcinoma or epithelial ovarian carcinoma, Stage III or IV, with either optimal or suboptimal residual disease following initial surgery. All patients must have had appropriate surgery for ovarian or peritoneal carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage.

Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor or adenocarcinoma N.O.S.

Patients must have adequate: ANC greater than or equal to 1, 500/ul, equivalent to CTC grade 1. Platelet greater than or equal to 100,000/ul (CTC grade 0-1), Creatinine less than or equal to 1.5 x institutional ULN (CTC grade 1), Bilirubin less than or equal to 1.5 x ULN (CTC grade 1), SGOT and alkaline phosphatase less than or equal to 2.5 x ULN (CTC grade 1), Neuropathy (sensory and motor) less than or equal to CTC grade 1.

Patients with a GOG performance status of 0, 1, or 2.

Patients who have signed an approved informed consent.

Patients must be entered no more than twelve weeks postoperatively.

Patients with unstable angina or those who have had a myocardial infarction within the past six months. Patients with evidence of abnormal cardiac conduction (e.g. bundle block, heart block) are eligible if there disease has been stable for past six months.

Exclusion Criteria:

Patients with a current diagnosis of epithelial ovarian tumor of low malignant potential (Borderline carcinomas). Patients with a prior diagnosis of a low malignant potential tumor that was surgically resected and who subsequently develop invasive adenocarcinoma, provided that they have not received prior chemotherapy for any ovarian tumor.

Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from other sites to the ovary and low malignant potential tumors including so called micropapillary serous carcinoma.

Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis. Prior radiation for localized cancer of the breast, head and neck, or skin, provided it was completed more than 3 years prior to registration, and that the patients remain free of recurrent or metastatic disease.

Patients with synchronous primary endometrial cancer or a part history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-B, less than 3mm invasion without vascular or lymphatic invasion, no poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO Grade 3 lesions.

With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.

Patients with acute hepatitis.

Patients with active infection that requires antibiotics.

Patients with ongoing gastrointestinal bleeding requiring blood product support.

Patients whose circumstances at the time of entry onto the protocol would not permit completion of study or required follow up.

Links

Registration Number: NCT00011986
Study Information on Clinical Trials Registry (clinicaltrials.gov)