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Complete title: A Randomized, Double-blind Phase 2 Study Comparing Gemcitabine and Cisplatin in Combination with OGX-427 or Placebo in Patients with Advanced Transitional Cell Carcinoma
|Research Study Number||20120003|
|Principal Investigator||Evan Yu, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Age 18 years and older at the time of consent
- Histologically documented metastatic or locally inoperable advanced TCC of the urinary tract (bladder, urethra, ureter and renal pelvis) (T4b, N2, N3 or M1 disease) NOTE: Certain mixed histologies that are predominately (> or = to 50%) TCC are eligible: squamous, adenocarcinoma, and undifferentiated. Mixed undifferentiated histology requires IHC consistent with a TCC origin. Mixed small-cell histologies are excluded.
- Measurable disease defined as at least one target lesion that has not been irradiated and can be accurately measured in at least one dimension by RECIST 1.1 criteria
- No prior systemic chemotherapy with the following exceptions:
- 1) Prior use of radiosensitizing single agent therapy is allowed
- 2) Prior neoadjuvant and adjuvant chemotherapy may be allowed
- Minimum of 21 days since prior major surgery or radiation therapy
- Karnofsky performance status > or = to 70%
- Required laboratory values at baseline:
- 1) ANC > or = to 1.5x1^9 cells/L
- 2) platelet count > or = to 125 x 1^9/
- 3) Calculated creatinine clearance > or = to 60 mL/minute
- 4) bilirubin < or = to 1.5 x ULN (< or = to 2.5 x ULN if secondary to Gilbert's disease)
- 5) AST and ALT < or = to 3.0 x ULN
- If of child-bearing potential, willing to use contraceptives
- Willing to give written informed consent
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Intravesical therapy within the last 3 months
- Documented brain metastasis or carcinomatous meningitis, treated or untreated. NOTE: Brain imaging is not required unless the patient has symptoms or physical signs of CNS disease.
- Peripheral neuropathy > or = to Grade 2
- Known serious hypersensitivity to gemcitabine, cisplatin or carboplatin
- Current serious, uncontrolled medical condition such as congestive heart failure, angina, hypertension, arrhythmia, diabetes mellitus, infection, etc. or any condition such as a psychiatric illness which in the opinion of the investigator would make the patient unacceptable for the protocol
- Cerebrovascular accident, myocardial infarction or pulmonary embolus within 6 months of randomization
- Active second malignancy (except non-melanomatous skin cancer): active secondary malignancy is defined as a current need for cancer therapy or a high possibility (>30%) of recurrence during the study
- Pregnant or nursing (must have a negative serum or urine pregnancy test within 72 hours prior to randomization)
- Participating in a concurrent clinical trial of an experimental drug, vaccine or device. Participation in an observational study is allowed.
Other exclusion criteria may apply.
Genitourinary Cancer; Solid Tumors; Transitional Cell Carcinoma (TCC)
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