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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00291785

Enrollment

Registered

2006-02-15

Start date

2004-01-31

Completion date

2008-09-30

Last updated

2011-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

colorectal cancer, camptothecin

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.

Interventions

DRUGCT-2106

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

DRUGFolinic acid

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

DRUG5-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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity	Each cycle

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026