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Phase 1 Study of the Combination of 1018 ISS, Irinotecan and Cetuximab in Patients With Metastatic Colorectal Cancer Previously Treated With a Fluoropyrimidine, Oxaliplatin or Irinotecan With or Without Bevacizumab


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Colorectal Neoplasms

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Trial Information

Phase 1 Study of the Combination of 1018 ISS, Irinotecan and Cetuximab in Patients With Metastatic Colorectal Cancer Previously Treated With a Fluoropyrimidine, Oxaliplatin or Irinotecan With or Without Bevacizumab


This is a Phase I, open-label study of escalating dose levels of 1018 ISS in combination
with irinotecan and cetuximab in patients with previously treated metastatic colorectal
cancer. Approximately 15 patients will be treated. The objectives of this study are to
establish a safe, tolerable, and active dose of 1018 ISS, determine tumor response, time to
disease progression, and overall survival in treated patients.

The safety and tolerability of 1018 ISS will be evaluated by periodic laboratory
assessments, physical examinations, and compilation of adverse events.

Once study patients have been consented, screened, and assigned to one of the dose levels of
1018 ISS, patients will receive two 4 week cycles of 1018 ISS therapy plus irinotecan every
other week and cetuximab weekly. Irinotecan and cetuximab will continue thereafter until
disease progression, unacceptable toxicity, or until the patient refuses treatment.


Inclusion Criteria:



- Signed, written, informed consent must be obtained from the patient or their legal
representative before any study-specific procedures are performed

- Confirmed diagnosis of adenocarcinoma of the colon or rectum not amenable to curative
surgery

- One or more prior systemic therapy regimens for metastatic cancer which must have
included a fluoropyrimidine (5-FU by infusion or capecitabine), oxaliplatin or
irinotecan with or without bevacizumab

Exclusion Criteria:

- Clinically significant obstructive symptoms, intestinal bleeding, or chronic or
recent acute gastrointestinal disorder with diarrhea as a major symptom

- History of unstable or deteriorating cardiovascular or cerebrovascular disease within
3 months before the first dose of protocol therapy

- Clinical evidence of brain metastases or central nervous system disease

- Pregnant or lactating women

- Serious medical or psychiatric illness

- Malignancy other than colorectal carcinoma within the past 2 years, except curatively
treated, superficial skin cancer or carcinoma in situ of the cervix

- Patients who have been on any experimental study or anti-tumor therapy, received
radiotherapy, or had prior surgery (except venous access device placement) within 28
days before the first dose of protocol therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Occurrence of adverse events

Outcome Time Frame:

16 weeks

Principal Investigator

Eduardo Martins, MD, DPhil

Investigator Role:

Study Director

Investigator Affiliation:

Dynavax Technologies Corporation

Authority:

United States: Food and Drug Administration

Study ID:

DV2-ONC-01

NCT ID:

NCT00403052

Start Date:

November 2006

Completion Date:

March 2008

Related Keywords:

  • Colorectal Neoplasms
  • colorectal
  • cancer
  • carcinoma
  • metastatic
  • colon
  • rectal
  • neoplasm
  • cetuximab
  • irinotecan
  • 1018 ISS
  • combination therapy
  • Neoplasms
  • Colorectal Neoplasms

Name

Location

Center for Cancer and Blood DisordersBethesda, Maryland  20817
Premiere OncologySanta Monica, California  90404
Lombardi Comprehensive Cancer Center, Georgetown UniversityWashington, District of Columbia  20007