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

NCT00291785 | Completed Phase 1

• 1 other identifier: CAM201
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; camptothecin

Outcome Measures

Primary Outcomes (1)

• Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity

  Each cycle

Interventions

CT-2106 DRUG

CT-2106 as 10 minute infusion on days 1, 15 \& 29 of each 42-day cycle

Folinic acid DRUG

Folinic acid 200 mg IV 1 hour after CT-2106 infusion on days 1, 2, 15, 16, 29 and 30

5-FU (fluorouracil) DRUG

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• CTI BioPharma: lead

Study Sites (2)

Policlinico Universitario "A.Gemelli"

Rome, Italy

Location

Istituto Clinico Humanitas

Rozzano, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

polyglutamate camptothecin; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Barone C., M.D.

  Policlinico Universitario "A.Gemelli"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 14, 2006
• First Posted: February 15, 2006
• Study Start: January 1, 2004
• Primary Completion: August 1, 2007
• Study Completion: September 1, 2008
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

IT (2)