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Study Summary
No. GOG 9917:.......Fallopian Tube; Ovary; Peritoneum......Judith Wolf......Gynecologic Oncology
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Study Summary Title
Study Summary
Number:
GOG 9917
Study Title:A Dose-Escalating Phase I Study with an Expanded Cohort to Assess the Feasibility of Intraperitoneal Carboplatin (NSC #214240) and Intravenous Paclitaxel (NSC #673089) in Patients with Previously Untreated Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
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Physician New Patient Referral
Name:Judith WolfPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gynecologic OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-7310
Contact us about clinical trials
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General Information
Disease Group:Fallopian Tube
Ovary
Peritoneum
Supported By:N/A
Phase of Study:Phase IReturn
Visit:
Every 21 days (one cycle) for a maximum of 6 cycles.
Treatment
Agents:
Carboplatin
Paclitaxel
Home Care:none
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
n/a
Description/
Intervention:
The goal of this clinical research study is to find the highest dose of the
chemotherapy drug carboplatin (given directly into the abdomen) that can be
safely combined with a standard dose of the chemotherapy drug paclitaxel (given
intravenously--through a needle in the vein), to treat patients with ovarian,
Fallopian tube, or primary peritoneal cancer.
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Study Objectives / Outcomes
Primary Objectives
1. To determine the maximum tolerated dose (MTD) of intraperitoneal carboplatin in combination with intravenous paclitaxel 175 mg/m2 during the first cycle of treatment in patients with chemo-naive epithelial ovarian, primary peritoneal, or fallopian tube carcinoma. The MTD is defined as the highest dose at which no more than 1 of 6 evaluable patients experiences a dose-limiting toxicity (DLT) during the first cycle of treatment.

2. Once the MTD is established, the feasibility of the regimen over multiple cycles will be evaluated in a second phase, 2-stage group sequential design.

Secondary Objectives
1. To assess the toxicity profile of the combination of intraperitoneal carboplatin with intravenous paclitaxel at 175 mg/m2 in this patient population.

2. To determine the response rate (in patients with measurable disease who are in the expanded cohort) and progression-free survival in patients who have chemo-naive epithelial ovarian, primary peritoneal, or fallopian tube carcinoma using the RECIST response criteria.
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Study Status Information
Study Activation / Registration Date:03/01/2006
IRB Review and Approval Date:02/01/2006
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:64
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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:1) Patients with a histologic diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube carcinoma, Stage II, III, or IV; with either optimal (less than or equal to 1 cm residual disease) or suboptimal residual disease following initial surgery. All patients must have had appropriate surgery for epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with appropriate tissue available for histologic evaluation.

2) Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma; mucinous adenocarcinoma; clear cell adenocarcinoma; transitional cell carcinoma; endometriod adenocarcinoma; adenocarcinoma NOS; undifferentiated carcinoma; mixed epithelial carcinoma; malignant Brenner's tumor.

3) Patients must have a GOG Performance Status of 0, 1, or 2.

4) Patients must be entered no more than 12 weeks postoperatively.

5) Patients must have adequate: (1) Bone Marrow Function: Absolute neutrophil count (ANC) >/= 1,500/ul; platelets >/= 100,000/ul. (2) Renal Function: Creatinine </= 2.0 mg%. (3) Hepatic Function: Bilirubin </= 1.5 x ULN. SGOT and alkaline phosphatase </= 3 x ULN. (4) Neurologic Function: Neuropathy (sensory and motor) </= CTCAE grade 1.

6) Patients must have signed an approved informed consent and authorization permitting the release of personal health information.

7) Patients must meet pre-entry requirements as indicated in the Patient/Participation Evaluation Pretreatment and Interim Testing table that follows. See Pre-Therapy column.

Exclusion Criteria:1) Patients who have received any prior treatment, other than initial debulking surgery, for the cancer being treated in this study.

2) 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 is permitted, if it was completed >/= 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease.

3) Patients with acute hepatitis or active infection requiring antibiotics.

4) Patients with active bleeding.

5) Patients with unstable angina or those who have had myocardial infarction within the past 6 months. Patients with evidence of cardiac conduction abnormalities (e.g., bundle branch block, heart block) are eligible if their cardiac status has been stable for the 6 months before study entry.

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

7) Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and localized breast cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients may have received prior adjuvant chemotherapy for localized breast cancer if the therapy was completed >/= 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.

8) Patients with synchronous primary endometrial cancer, or past history of endometrial cancer, are excluded, unless all of the following conditions are met: (1) Stage not greater than I-B; (2) Less than 3mm invasion without vascular or lymphatic invasion; (3) No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO Grade 3 lesions.

9) Patients with epithelial tumors of low malignant potential (borderline tumors).

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Links
Registration Number: NCT00079430
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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