Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
48 participants
INTERVENTIONAL
2004-01-31
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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CT-2106
CT-2106 as 10 minute infusion on days 1, 15 \& 29 of each 42-day cycle
Folinic acid
Folinic acid 200 mg IV 1 hour after CT-2106 infusion on days 1, 2, 15, 16, 29 and 30
5-FU (fluorouracil)
5-FU following CT-2106 and folinic acid infusions @ 400 mg/m² IV bolus then 5-FU 600 mg/m² as a 22 hour IV infusion on Days 1, 2, 15, 16, 29, and 30.
Eligibility Criteria
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Inclusion Criteria
* At least one measurable lesion according to RECIST criteria for both Phase I and II
* ECOG performance status 0 or 1
* Adequate hematologic, renal and hepatic function
* Wash out period of at least 4 weeks from surgery, 4 weeks from radiotherapy
Exclusion Criteria
* Pregnant or lactating patients
* Prior treatment with camptothecins
* Presence or history of CNS metastasis or carcinomatous leptomeningitis
* Current active infection per investigator assessment
* Unresolved bowel obstruction or partial obstruction, uncontrolled Crohn's disease or ulcerative colitis
* Current history of chronic diarrhea greater than or equal to grade 1 (CTCAE version 3)
18 Years
ALL
No
Sponsors
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CTI BioPharma
INDUSTRY
Responsible Party
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Cell Therapeutics, Inc.
Principal Investigators
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Barone C., M.D.
Role: PRINCIPAL_INVESTIGATOR
Policlinico Universitario "A.Gemelli"
Locations
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Policlinico Universitario "A.Gemelli"
Rome, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Countries
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Other Identifiers
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CAM201
Identifier Type: -
Identifier Source: org_study_id
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