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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Policlinico Universitario "A.Gemelli", Rome, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

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

Time frame: Each cycle

Sponsors and collaborators

Lead sponsor

CTI BioPharma

Industry

Registry information

Official study 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

Important dates

Study start: 2004
Primary completion: 2007
Study completion: 2008
First posted: Feb 15, 2006
Registry last updated: Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed