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An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of 5 FU/FA and Oxaliplatin (Modified FOLFOX 6) in Combination With IMC-1121B or IMC-18F1 or Without Investigational Therapy as Second Line Therapy in Patients With Metastatic Colorectal Cancer Following Disease Progression on First Line Irinotecan-based Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colon Cancer, Rectal Cancer

Thank you

Trial Information

An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of 5 FU/FA and Oxaliplatin (Modified FOLFOX 6) in Combination With IMC-1121B or IMC-18F1 or Without Investigational Therapy as Second Line Therapy in Patients With Metastatic Colorectal Cancer Following Disease Progression on First Line Irinotecan-based Therapy


The purpose of this study is to evaluate the progression-free survival (PFS) in patients
with metastatic colorectal cancer when treated with 1 of 3 modified FOLFOX-6 (folinic acid
[FA] + fluorouracil [5-FU] + oxaliplatin [mFOLFOX-6])-based regimens, as second-line
therapy.

During 2010, there has been an identified shortage of injectable folinic acid (FA) in the
United States. Levo-folinic acid (LFA) will be allowed as a substitute for FA in the
mFOLFOX-6 chemotherapy regimen in circumstances in which FA is not available, to facilitate
continuity of patient care.


Inclusion Criteria:



- Disease progression on an irinotecan-based first-line chemotherapy regimen (ie
FOLFIRI or CAPIRI [capecitabine + irinotecan], with or without bevacizumab)

- Age ≥ 18 years

- Life expectancy of ≥ 6 months

- ECOG PS (Eastern Cooperative Oncology Group Performance Status) 0-1 at study entry

- Agrees to adequate contraception during the study period and for 12 weeks after the
last dose of study medication

- Provided signed informed consent

Exclusion Criteria:

- Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable
or metastatic CRC (Prior oxaliplatin-based adjuvant chemotherapy is allowed if the
last dose of oxaliplatin was administered > 12 months prior to randomization)

- Has documented and/or symptomatic brain or leptomeningeal metastases

- Has an ongoing or active infection, symptomatic or poorly controlled cardiac
arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled
medical disorders

- On chronic non-topical corticosteroid treatment. A patient discontinuing such
treatment > 3 months prior to randomization is eligible

- Has uncontrolled or poorly controlled hypertension on a standard regimen of
antihypertensive therapy

- Has a concurrent active malignancy. A patient with 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 undergone major surgery within 28 days prior to randomization

- Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to
randomization

- Has an elective or planned major surgery to be performed during the course of the
trial

- Has a history of inflammatory bowel disease requiring pharmacological and/or surgical
intervention in the 12 months prior to randomization

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Description:

PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by RECIST v1.1, or death from any cause, whichever is first.

Outcome Time Frame:

31 Weeks

Safety Issue:

No

Principal Investigator

E-mail: ClinicalTrials@ImClone.com

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

Canada: Health Canada

Study ID:

13942

NCT ID:

NCT01111604

Start Date:

August 2010

Completion Date:

November 2014

Related Keywords:

  • Colon Cancer
  • Rectal Cancer
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Adenocarcinoma
  • Antibodies, Monoclonal
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms

Name

Location

ImClone Investigational SiteCleveland, Ohio  44134
ImClone Investigational SiteGreenville, South Carolina  29605
ImClone Investigational SiteMemphis, Tennessee  38104