SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating⦠(NCT00020774) | Clinical Trial Compass
WithdrawnPhase 2
SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer
0Started 1998-10
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of SCH 66336 with or without gemcitabine followed by surgery with that of surgery alone in treating patients who have primary liver cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically confirmed resectable primary hepatocellular carcinoma or cholangiocarcinoma
* 18 and over
* Karnofsky 70-100%
* Hematopoietic: Absolute neutrophil count greater than 1,500/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 9 g/dL Hepatic:
* Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT or SGPT no greater than 5 times ULN
* Albumin at least 2.5 g/dL INR less than 1.3 Renal:
* Creatinine no greater than 1.5 mg/dL
* Cardiovascular: QTc prolongation no greater than 440 msec Other:
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* At least 6 weeks since prior radiotherapy and recovered
* At least 6 weeks since prior surgery and recovered
* At least 6 weeks since prior systemic therapy and recovered
Exclusion Criteria:
* metastatic disease outside of the liver
* pregnant or nursing
* malabsorption or other gastrointestinal (GI) condition that would preclude ability to take oral medication and/or GI absorption (e.g., partial small bowel obstruction)
* non-malignant systemic disease that would preclude study
* active uncontrolled infection No grade II nausea or grade I vomiting despite antiemetic medication
* concurrent immunotherapy Chemotherapy: No other concurrent chemotherapy
* concurrent hormonal therapy including estrogen therapy
* concurrent oral contraceptives or other hormonal methods Concurrent megestrol acetate allowed
* concurrent corticosteroidā¦