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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: CT-2106
* Drug: Folinic acid
* Drug: 5-FU (fluorouracil)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity |  | Each cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, camptothecin