NCT00539877 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Guichard S, Chatelut E, Lochon I, Bugat R, Mahjoubi M, Canal P
Comparison of the pharmacokinetics and efficacy of irinotecan after administration by the intravenous versus intraperitoneal route in mice. Cancer Chemother Pharmacol. 1998;42(2):165-70.
Maruyama M, Nagahama T, Yuasa Y
Intraperitoneal versus intravenous CPT-11 for peritoneal seeding and liver metastasis. Anticancer Res. 1999 Sep-Oct;19(5B):4187-91.
Rosen HR, Jatzko G, Repse S, Potrc S, Neudorfer H, Sandbichler P, Zacherl J, Rabl H, Holzberger P, Lisborg P, Czeijka M
Adjuvant intraperitoneal chemotherapy with carbon-adsorbed mitomycin in patients with gastric cancer: results of a randomized multicen
Rothenberg ML, Liu PY, Braly PS, Wilczynski SP, Hannigan EV, Wadler S, Stuart G, Jiang C, Markman M, Alberts DS
Combined intraperitoneal and intravenous chemotherapy for women with optimally debulked ovarian cancer: results from an intergroup phase II tr

Phase I Study of Interperitoneal Chenotherapy in Patients With Gastric Adenocarainoma With Peritoneal Seeding

Clinical trial NCT00539877 - References