A Study of Picoplatin in Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00478946|
Recruitment Status : Unknown
Verified January 2009 by Poniard Pharmaceuticals.
Recruitment status was: Active, not recruiting
First Posted : May 25, 2007
Last Update Posted : January 21, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: (FOLPI) Picoplatin with 5-FU and Leucovorin Drug: FOLPI Drug: FOLFOX||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Open-Label Study of Picoplatin in Combination With 5-Fluorouracil and Leucovorin as Initial Therapy in Subjects With Metastatic Colorectal Cancer|
|Study Start Date :||April 2006|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||June 2010|
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.
Drug: (FOLPI) Picoplatin with 5-FU and Leucovorin
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.Drug: FOLPI
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.
Active Comparator: 2
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.
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.
- dose-limiting toxicity [ Time Frame: within the first four weeks of treatment ]
- maximum tolerated dose [ Time Frame: within the first two cycles of treatment ]
- safety and efficacy [ Time Frame: duration of the study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478946
|Leningrad Regional Oncology Center, Chemotherapy Department - Phase 2|
|Kuzmolovsky Village, Vsevolozhsk, Russian Federation, 188663|
|Regional Oncology Center - Phase 2|
|Astrakhan, Russian Federation, 414041|
|Chelyabinsk Regional Oncology Center - Phase 1|
|Chelyabinsk, Russian Federation, 454087|
|Regional Oncology Center, Chemotherapy Department - Phase 2|
|Engels, Russian Federation, 413115|
|Kazan Oncology Center|
|Kazan, Russian Federation, 420111|
|Blokhin Russian Oncology Research Center - Phase 1|
|Moscow, Russian Federation, 115478|
|Semashko Central Clinical Hospital #2 - Phase 1|
|Moscow, Russian Federation, 129128|
|Medical Radiology Research Center of Russian Academy of Medical Sciences- Phase 1|
|Obninsk, Russian Federation, 249036|
|Republic Oncology Center of the Ministry of Healthcare of Karelia Republic - Phase 2|
|Petrozavodsk, Russian Federation, 185007|
|Rostov Research Institute of Oncology- Phase 2|
|Rostov-na-Dony, Russian Federation, 350086|
|St. Petersburg Academy of Postgraduate Education - Phase 2|
|St. Petersburg, Russian Federation, 194291|
|St. Petersburg Mechnikov State Medical Academy - Phase 2|
|St. Petersburg, Russian Federation, 195067|
|St. Petersburg City Oncology Center - Phase 1|
|St. Petersburg, Russian Federation, 198255|
|Regional Clinical Oncology Center - Phase 2|
|Ulyanovsk, Russian Federation, 432063|
|Voronezh Regional Clinical Oncology Center - Phase 2|
|Voronezh, Russian Federation, 394000|
|Yaroslavl Regional Oncology Center - Phase 1|
|Yaroslavl, Russian Federation, 150054|
|Study Director:||Robert Earhart, MD, PhD||Poniard Pharmaceuticals|