Phase I/II CT 2106 and 5-FU/FA in Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Phase I/II Study of CT-2106 in Combination With Infusional 5-fluorouracil/Folinic Acid (5-FU/FA)(de Gramont Schedule) as Second Line in Patients With Metastatic Colorectal Cancer Failing an Oxaliplatin Plus 5-FU/FA Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291785
• Other study ID #: CAM201
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 14, 2006
• Last updated: June 6, 2011
• Start date: January 2004
• Est. completion date: September 2008

Study information

• Verified date: June 2011
• Source: CTI BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

CT-2106, a camptothecin (CPT) conjugate, is a new generation of topoisomerase I inhibitors designed to deliver higher, more effective chemotherapy to tumor tissue with less toxicity to normal tissues. The objective of this study is to determine the dose limiting toxicities, safety profile and antitumor activity of CT-2016 in combination with 5-FU and folic acid for the treatment of colorectal cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven metastatic colorectal adenocarcinoma, failing one prior treatment containing oxaliplatin plus 5-FU/FA

• 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:

• Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix.

• 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Italy	Policlinico Universitario "A.Gemelli"	Rome
Italy	Istituto Clinico Humanitas	Rozzano

Sponsors (1)

Lead Sponsor	Collaborator
CTI BioPharma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity		Each cycle	Yes