Clinical trial NCT00102622 (phase 1, status: terminated)
Conditions: ovarian cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: paclitaxel
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Reason stopped: 
    phase i/ii study that did not progress to phase ii
  
Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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%.