Status:
TERMINATED
Intraperitoneal tgDCC-E1 and Intravenous Paclitaxel in Women With Platinum-Resistant Ovarian Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
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, plat...
Detailed Description
Primary Objective * To evaluate toxicity and establish the maximum tolerated dose (MTD) of intraperitoneal tgDCC-E1A in combination with intravenous paclitaxel. * To measure tumor response of intrape...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years
- Recurrent epithelial ovarian cancer or primary peritoneal cancer with histologic confirmation of the original tumor. Recurrent disease may be manifested as an elevated cancer antigen (CA)-125 using the following criteria: (a) increase in CA-125 to at least 2 times the upper limit of normal (assayed on 2 occasions at least 7 days apart) for subjects with a history of normal pre-treatment values or values that normalized with the most recent treatment - OR - (b) increase in CA-125 to 2 times the lowest observed value on the most recent treatment (assayed on two occasions at least 7 days apart) for subjects whose CA-125 did not normalize with the most recent treatment.
- 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.
- 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.
- A Zubrod performance status of two or less.
Exclusion
- Previous administration of tgDCC-E1A.
- Progression on any taxane-containing regimen, or recurrent within 6 months of receiving a weekly taxane-containing regimen.
- Previous radiation to more than 25% of marrow-bearing areas.
- Any of the following laboratory values: Hemoglobin \<9.0 gm/dl, absolute neutrophil count (ANC) \<1.5 K/ml, platelet \<100 K/ml, creatinine \>2 mg/dl, bilirubin \>2 mg/dl, Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT)\>2 times the upper limit of normal, or abnormal coagulation profiles (\>2 seconds beyond upper range of normal Prothrombin Time (PT) or Partial thromboplastin time (PTT)).
- Known human immunodeficiency virus (HIV)-positive status or active systemic infection.
- History of other invasive malignancies, except for non-melanoma skin cancer, unless there is no evidence of other cancer within the past 5 years.
- Patients with grade 2 or greater neurotoxicity.
- Patients with unstable angina or those who have had a myocardial infarction within the past six months. Patients 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%.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00102622
Start Date
December 1 2004
End Date
July 1 2012
Last Update
November 13 2018
Active Locations (1)
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1
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030