A Phase I Open-Label Study of Picoplatin in Combination With 5-Fluorouracil and Leucovorin as Initial Therapy in Subjects With Metastatic Colorectal Cancer
Sponsor study identifier
interventional
43
1 country
16
Study Start
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Colorectal cancer is a type of cancer that begins in the large intestine (colon) or the rectum (end of the colon). Several drugs are often given in combination to treat colorectal cancer. One of the most active treatment combinations is known as FOLFOX, which is a combination of 5-fluorouracil (5-FU), leucovorin, and oxaliplatin. Oxaliplatin is a type of platinum drug and was approved by the FDA in 2004. While generally well-tolerated, oxaliplatin may cause toxicity to the nerves, such as sensory loss or cold sensitivity. Picoplatin is a new type of platinum drug that has shown activity with 5-FU in pre-clinical studies and has undergone extensive Phase 1 and Phase 2 testing in a variety of cancers. No significant nerve toxicity has been seen in previous studies of picoplatin. This study will review the safety and effectiveness of FOLPI, which is the combination of 5-FU and leucovorin with picoplatin in participants with colorectal cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
May 23, 2007
Actual (reported)May 25, 2007
Actual (reported)December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
dose-limiting toxicity
within the first four weeks of treatment
maximum tolerated dose
within the first two cycles of treatment
safety and efficacy
duration of the study
Picoplatin, 150 mg/m2, 5-FU and leucovorin (q 4 weeks, Schedule B). Leucovorin, 400 mg/m2 in D5W and leucovorin (± picoplatin) will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2,400 mg/m2 in D5W administered as a 46-hour continuous infusion.
FOLFOX Oxaliplatin 85 mg/m2, as a 2-hour infusion Leucovorin (400 mg/m2 in D5W) and Oxaliplatin. Leucovorin + oxaliplatin will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2400 mg/m2 in D5W administered as a 46-hour continuous infusion.
Picoplatin, 150 mg/m2, 5-FU and leucovorin (q 4 weeks, Schedule B). Leucovorin, 400 mg/m2 in D5W and leucovorin (± picoplatin) will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2,400 mg/m2 in D5W administered as a 46-hour continuous infusion.
Picoplatin, 150 mg/m2 to be administered with every alternate cycle of 5-FU and leucovorin (q 4 weeks, Schedule B). Leucovorin, 400 mg/m2 in D5W, will be administered as a 2-hour infusion, either alone or, if the patient is to receive picoplatin that cycle, at the same time as picoplatin, in separate bags using a Y-line. The leucovorin (± picoplatin) will be followed by a 5-FU bolus of 400 mg/m2 and then by 5-FU, 2,400 mg/m2 in D5W administered as a 46-hour continuous infusion.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
(FOLPI) Picoplatin with 5-FU and Leucovorin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordLeningrad Regional Oncology Center, Chemotherapy Department - Phase 2
Kuzmolovsky Village, Vsevolozhsk, 188663, Russia
Regional Oncology Center - Phase 2
Astrakhan, 414041, Russia
Chelyabinsk Regional Oncology Center - Phase 1
Chelyabinsk, 454087, Russia
Regional Oncology Center, Chemotherapy Department - Phase 2
Engel's, 413115, Russia
Kazan Oncology Center
Kazan', 420111, Russia
Blokhin Russian Oncology Research Center - Phase 1
Moscow, 115478, Russia
Semashko Central Clinical Hospital #2 - Phase 1
Douillard JY, Schiller J. ZD0473 combined with other chemotherapeutic agents for the treatment of solid malignancies. Eur J Cancer. 2002 Dec;38 Suppl 8:S25-31. doi: 10.1016/s0959-8049(02)80020-x.
Beale P, Judson I, O'Donnell A, Trigo J, Rees C, Raynaud F, Turner A, Simmons L, Etterley L. A Phase I clinical and pharmacological study of cis-diamminedichloro(2-methylpyridine) platinum II (AMD473). Br J Cancer. 2003 Apr 7;88(7):1128-34. doi: 10.1038/sj.bjc.6600854.
Robert Earhart, MD, PhD
Poniard Pharmaceuticals
First Submitted
May 23, 2007
First Posted
May 25, 2007
Study Start
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Estimated (date passed)Oxaliplatin 85 mg/m. Leucovorin (400 mg/m2 in D5W). Oxaliplatin and leucovorin Leucovorin + oxaliplatin 5-FU bolus of 400 mg/m2 and then by 5-FU, 2400 mg/m2 in D5W administered as a 46-hour continuous infusion.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Moscow, 129128, Russia
Medical Radiology Research Center of Russian Academy of Medical Sciences- Phase 1
Obninsk, 249036, Russia
Republic Oncology Center of the Ministry of Healthcare of Karelia Republic - Phase 2
Petrozavodsk, 185007, Russia
Rostov Research Institute of Oncology- Phase 2
Rostov-na-Dony, 350086, Russia
St. Petersburg Academy of Postgraduate Education - Phase 2
Saint Petersburg, 194291, Russia
St. Petersburg Mechnikov State Medical Academy - Phase 2
Saint Petersburg, 195067, Russia
St. Petersburg City Oncology Center - Phase 1
Saint Petersburg, 198255, Russia
Regional Clinical Oncology Center - Phase 2
Ulyanovsk, 432063, Russia
Voronezh Regional Clinical Oncology Center - Phase 2
Voronezh, 394000, Russia
Yaroslavl Regional Oncology Center - Phase 1
Yaroslavl, 150054, Russia
Raynaud FI, Boxall FE, Goddard PM, Valenti M, Jones M, Murrer BA, Abrams M, Kelland LR. cis-Amminedichloro(2-methylpyridine) platinum(II) (AMD473), a novel sterically hindered platinum complex: in vivo activity, toxicology, and pharmacokinetics in mice. Clin Cancer Res. 1997 Nov;3(11):2063-74.
Holford J, Raynaud F, Murrer BA, Grimaldi K, Hartley JA, Abrams M, Kelland LR. Chemical, biochemical and pharmacological activity of the novel sterically hindered platinum co-ordination complex, cis-[amminedichloro(2-methylpyridine)] platinum(II) (AMD473). Anticancer Drug Des. 1998 Jan;13(1):1-18.
Holford J, Sharp SY, Murrer BA, Abrams M, Kelland LR. In vitro circumvention of cisplatin resistance by the novel sterically hindered platinum complex AMD473. Br J Cancer. 1998;77(3):366-73. doi: 10.1038/bjc.1998.59.
Rogers P, Boxall FE, Allott CP, Stephens TC, Kelland LR. Sequence-dependent synergism between the new generation platinum agent ZD0473 and paclitaxel in cisplatin-sensitive and -resistant human ovarian carcinoma cell lines. Eur J Cancer. 2002 Aug;38(12):1653-60. doi: 10.1016/s0959-8049(02)00107-7.
Sharp SY, O'Neill CF, Rogers P, Boxall FE, Kelland LR. Retention of activity by the new generation platinum agent AMD0473 in four human tumour cell lines possessing acquired resistance to oxaliplatin. Eur J Cancer. 2002 Nov;38(17):2309-15. doi: 10.1016/s0959-8049(02)00244-7.
Plasencia C, Abad A, Martinez-Balibrea E, Taron M. Antiproliferative effects of ZD0473 (AMD473) in combination with 5-fluorouracil or SN38 in human colorectal cancer cell lines. Invest New Drugs. 2004 Nov;22(4):399-409. doi: 10.1023/B:DRUG.0000036682.99818.71.
Murakami H, Tamura T, Yamada Y, Yamamoto N, Ueda Y, Shimoyama T, Saijo N. ZD0473 pharmacokinetics in Japanese patients: a Phase I dose-escalation study. Eur J Cancer. 2002 Dec;38 Suppl 8:S1-5. doi: 10.1016/s0959-8049(02)80012-0.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 21, 2009
Record last verified: 2009-01
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