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Study Summary
No. ID02-321:.......Ovary......Naoto Ueno......Gynecologic Oncology
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Study Summary Title
Study Summary
Number:
ID02-321
Study Title:A Phase I/II RANDOMIZED Study of Intraperitoneal tgDCC-E1A and Intravenous Paclitaxel in Women with Platinum-Resistant Ovarian Cancer
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Physician New Patient Referral
Name:Naoto UenoPatients 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:OvarySupported By:N/A
Phase of Study:Phase I/Phase IIReturn
Visit:
Weekly for six treatments. An additional six treatments of therapy may be added
if disease is stable or responding to treatment after restaging.
Treatment
Agents:
E1A
Taxol
Home Care:None.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Not applicable. This is an outpatient study.
Description/
Intervention:
The goal of this clinical research study is to find the highest safe dose of
intraperitoneal tgDCC-E1A that can be given in combination with paclitaxel as a
treatment for patients with recurrent, platinum-resistant ovarian cancer. How
the cancer responds to this treatment will also be studied.
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Study Objectives / Outcomes

Primary:

· To evaluate toxicity and establish the maximum tolerated dose (MTD) of intraperitoneal (IP) tgDCC-E1A in combination with intravenous (IV) paclitaxel
· To measure tumor response of intraperitoneal (IP) tgDCC-E1A in combination with intravenous (IV) paclitaxel and compare to intravenous (IV) paclitaxel alone

Secondary:

· To measure time to progression and overall survival
· To examine the biological effects of combined tgDCC-E1A and paclitaxel in ovarian cancer cells as measured by laboratory testing

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Study Status Information
Study Activation / Registration Date:12/01/2004
IRB Review and Approval Date:04/16/2003
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:N/A
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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) Age > 18 years old. This study was written for an adult population (the incidence of this disease in the pediatric population is rare.

2) Recurrent EOC or PPC with histologic confirmation of the original tumor. Recurrent disease may be manifested as an elevated CA-125 using the following criteria (Vergote et al., 2000): (A) Increase in CA-125 to at least 2x the ULN (assayed on 2 occasions at least 7 days apart) for subjects with a history of normal pre-treatment values or values that normalized with most recent treatment. -OR- (B) Increase in CA-125 to 2x the lowest observed value on most recent treatment (assayed on two occasions at least 7 days apart) for subjects whose CA-125 did not normalize with most recent treatment.

3) Platinum-resistant disease, defined as recurrence less than six months after discontinuation of treatment with platinum therapy or platinum-refractory disease, defined as progression on a platinum-containing regimen.

4) A treatment-free interval of at least three weeks for cytotoxic therapies, radiation therapy, or other experimental drugs prior to first treatment on this protocol.

5) A Zubrod performance status of two or less.

6) Patients with known hypersensitivity to platinum compounds, who have failed a desensitization regimen, or in the opinion of the investigator, are not good candidates for desensitization, are eligible.

Exclusion Criteria:1) Previous administration of tgDCC-E1A.

2) Progression on any taxane-containing regimen, or recurrent within 6 months of receiving a weekly taxane-containing regimen.

3) Previous radiation to more than 25% of marrow-bearing areas.

4) Any of the following laboratory values: Hemoglobin <9.0 gm/dl, ANC <1.5 K/mL, platelet <100 K/mL, creatinine >2 mg/dl, bilirubin >2 mg/dl, AST or ALT >2 times the upper limit of normal, or abnormal coagulation profiles (>2 seconds beyond upper range of normal PT or PTT).

5) Known HIV-positive status or active systemic infection.

6) History of other invasive malignancies, except for non-melanoma skin cancer, unless there is no evidence of other cancer within the past five years.

7) Patients with grade 2 or greater neurotoxicity.

8) Patients with unstable angina or those who have had a myocardial infarction within the past six months. Patient with evidence of abnormal cardiac conduction are eligible if their disease has been stable for the past six months. Patients with an ejection fraction under 40%.

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Links
Registration Number: NCT00102622
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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