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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Each cycle

Safety Issue:

Yes

Principal Investigator

Barone C., M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Policlinico Universitario "A.Gemelli"

Authority:

United States: Food and Drug Administration

Study ID:

CAM201

NCT ID:

NCT00291785

Start Date:

January 2004

Completion Date:

September 2008

Related Keywords:

  • Colorectal Cancer
  • colorectal cancer
  • camptothecin
  • Colorectal Neoplasms

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