Study of Indisulam and Capecitabine in Cancer Patients
Author Information
Author(s): Siegel-Lakhai W S, Zandvliet A S, Huitema A D R, Tibben M M, Milano G, Girre V, Diéras V, King A, Richmond E, Wanders J, Beijnen J H, Schellens J H M
Primary Institution: The Netherlands Cancer Institute/Slotervaart Hospital
Hypothesis
The study aims to determine the recommended dose of indisulam in combination with capecitabine and evaluate their pharmacokinetics in patients with solid tumors.
Conclusion
The combination of 500 mg/m² indisulam and 1250 mg/m² capecitabine is safe and well tolerated during multiple treatment cycles.
Supporting Evidence
- The recommended dose of indisulam was established at 700 mg/m² and capecitabine 1250 mg/m² BID.
- Partial response was confirmed in two patients, one with colon carcinoma and the other with pancreatic carcinoma.
- Seventeen patients had stable disease.
Takeaway
Doctors tested a new cancer treatment combining two drugs, and found a safe dose that works well for patients over several cycles.
Methodology
Patients received escalating doses of indisulam and capecitabine over multiple treatment cycles, with pharmacokinetic analysis performed.
Limitations
The study had a small sample size and was limited to patients with solid tumors who were refractory to standard therapy.
Participant Demographics
{"gender":{"male":22,"female":13},"age":{"median":56,"range":"20-70"},"race":{"Caucasian":35},"tumor_types":{"pancreas":10,"ACUP":5,"colon":5,"stomach":3,"rectum":2,"NSCLC":2,"oesophagus":1,"Ewing bone sarcoma":1,"sclerosing osteosarcoma":1,"melanoma":1,"cholangiocarcinoma":1,"squamous cell carcinoma":1,"thymoma":1,"endometrium":1}}
Digital Object Identifier (DOI)
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