Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Approved-not yet active	18 and over	Pharmaceutical / Industry	CP12-0709 NCT00862784

Trial Description

Summary

The purpose of this study is to test how long patients with colorectal cancer live without progressive disease when being treated with IMC-1121B and the modified FOLFOX-6 chemotherapy.

Further Study Information

The purpose of this study is to evaluate the progression-free survival (PFS) in patients with metastatic colorectal cancer when treated with the monoclonal antibody IMC-1121B in combination with the modified FOLFOX-6 (folinic acid [FA] + fluorouracil [5-FU0 + oxaliplatin, mFOLFOX-6) chemotherapy regimen as first-line therapy.

Eligibility Criteria

Inclusion Criteria:

• Have histologically-confirmed adenocarcinoma of the colon or rectum that is locally-advanced or metastatic and unresectable

• Have at least one unidinemsionally-measurable target lesion (≥ 2cm with conventional techniques or ≥ 1cm with spiral CT scan or MRI as defined by RECIST); target lesions must not lie within an irradiated area.Patients with locally advanced rectal carcinoma who have undergone previous radiation must have documented evidence of disease progression in the pelvis.

• Life expectancy of ≥ months

• ECOG PS 0-1 at study entry

• Has adequate hematologic function as evidenced by an ANC ≥ 1500/μL, hemoglobin ≥ 10g/dL, and platelets ≥ 100,000/μL

• Adequate hepatic function as defined by: total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3.0 x ULN [or 5.0 x ULN in the case of liver metastases], and serum albumin ≥ LLN or (if < LLN) within 10% of the LLN

• Adequate renal function as defined by a serum creatinine ≤ 1.5 x ULN, creatinine clearance (measured via 24-hour urine collection) ≥ 60mL/min

• Urinary protein ≤ 1+ on dipstick or routine urinalysis; if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine for protein must demonstrate < 1000mg of protein in 24 hours

• Adequate coagulation function as defined by INR ≤ 1.5 and PTT ≤ 5 seconds above the ULN. Patients on full-dose anticoagulation must be on a stable dose of oral anticoagulant or LMW heparin and if on warfarin, must have an INR between 2 and 3 and no active bleeding or pathological condition present that carries a high risk of bleeding (eg, tumor involving major vessels or known varices)

• Has resolution to Grade ≤ 1 by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 of all significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy which must have resolved to Grade 0.

• Agrees to adequate contraception during the study period and for 8 weeks after the last dose of study treatment

• Has provided signed informed consent

Exclusion Criteria:

• Has received prior systemic chemotherapy for locally-advanced unresectable or metastatic CRC. Prior adjuvant chemotherapy is allowed if disease progression has been documented > 6 months after the end of the last cycle of adjuvant chemotherapy or > 12 months after the end of the last cycle of adjuvant oxaliplatin-containing regimens

• Has documented and/or symptomatic brain or leptomeningeal metastases

• Has participated in clinical studies of nonapproved experimental agents or procedures within 12 weeks of study entry

• Has received previous therapy with monoclonal antibodies

• Has received previous therapy with any agent that targets VEGF or VEGFR-2 (including multi-targeted tyrosine kinase inhibitors)

• Ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator

• On chronic nontopical corticosteroid treatment for > 6 months at doses > 10 mg/day of prednisolone or equivalent before study entry, which in the opinion of the investigator could compromise the patient or the study

• Known dihydropyrimidine dehydrogenase (DPD) deficiency

• Known allergy to any of the treatment components

• Acute or subacute intestinal obstruction

• Uncontrolled or poorly controlled hypertension on a standard regimen of anti-hypertensive therapy

• Concurrent active malignancy other than adequately treated nonmelanomatous skin cancer, other noninvasive carcinoma, or in situ neoplasm. Previous history of malignancy is eligible, provided that he/she has been disease free for > 3 years.

• If female, is pregnant (confirmed by serum beta human chorionic gonadotropin [βHCG] test) or lactating

• Has received a prior autologous or allogeneic organ or tissue transplantation

• Has interstitial pneumonia or interstitial fibrosis of the lung, which in the opinion of the investigator could compromise the patient or the study

• Has pleural effusion or ascites that causes > Grade 1 dyspnea

• Has psychological, familial, sociological, or geographical conditions which do not permit adequate study follow-up, compliance with the protocol, or signature of Informed Consent

• Has undergone major surgery within 28 days prior to the first dose of study medication, or subcutaneous venous access device placement within 7 days prior to the first dose of study medication

Trial Contact Information

Trial Lead Organizations/Sponsors

ImClone Systems, Incorporated

Tim Asmis, MD

Principal Investigator

Denise Barth		Ph: 619-546-6917
		Email: denise.barth@imclone.com

Lisa Loftus-Moss		Ph: 908-541-2230
		Email: lisa.loftus-moss@imclone.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00862784
Information obtained from ClinicalTrials.gov on March 27, 2009