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”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2007

Intervention(s) in this Clinical Trial

• Drug: CT-2106
  • CT-2106 as 10 minute infusion on days 1, 15 & 29 of each 42-day cycle
• Drug: Folinic acid
  • Folinic acid 200 mg IV 1 hour after CT-2106 infusion on days 1, 2, 15, 16, 29 and 30
• Drug: 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.

Primary Measures

• Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity
  • Time Frame: Each cycle
    Safety Issue?: Yes

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Cell Therapeutics

Overall Clinical Trial Officials and Contacts

Barone C., M.D. Principal Investigator Policlinico Universitario "A.Gemelli"  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00291785

Study ID Number: CAM201

ClinicalTrials.gov Identifier: NCT00291785

Health Authority: United States: Food and Drug Administration