Phase I Trials
General Eligibility Criteria:
Biopsy-proven cancer
PS < 2 with life expectancy of > 12 weeks and adequate organ function
No active brain metastasis (must have completed local therapy and be off steroids, anticonvulsants)
18 years or older, unless otherwise specified.
No chemotherapy or therapeutic radiotherapy 3-4 weeks prior to starting on study.
ET-743/Capecitabine
Mechanism: ET-473 is a natural alkaloid that inhibits gene activation by both a promoter-specific mechanism and through the transcription-dependent nucleotide excision-repair system.
Regimen: (21-day cycle) ET-743 0.4 -1.3 mg/m2 IV on Day 1; Capecitabine 800 -1000 mg/m2 PO BID on Days 2-15. Patients must have normal LFTs and a central line.
Study Status: Opened October 2002. 22 patients have been enrolled. Combination is well tolerated. A partial response was noted in a patient with cholangiocarcinoma and prolonged stabilization (> 10 mos.) in a patient with chondrosarcoma and a patient with ovarian cancer.
Potential Target Tumors: sarcoma, breast, colorectal, and ovarian cancers.
*******************************
ET-743+Paclitaxel
ET-743 is a tetrahydroisoquinoline alkaloid isolated from a natural product of marine origin (sea squirt). It binds to the minor groove of DNA producing structural abnormalities. This is a combination study of sequential intravenous administration of paclitaxel on day 1, followed by ET-743 on day 2, every 2 weeks (Consider for all solid tumors and lymphomas, particularly soft-tissue sarcomas and breast cancer)