Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma

March 30, 2010 updated by: HiberCell, Inc.

A Phase 1b, Safety, PK, and Efficacy, Multicenter, Dose-Escalating Study of Imprime PGG in Combination With Cetuximab With and Without Irinotecan Therapy in Patients With Recurrent/Progressive Colorectal Carcinoma Following Treatment With a 5-FU Regimen.

Phase 1b, safety, pharmacokinetic, and efficacy, multicenter, dose-escalating Study of Imprime PGG™ Injection dosed in combination with Cetuximab and concomitant irinotecan therapy. Enrolled patients will have a confirmed diagnosis of recurrent or progressive colorectal carcinoma following treatment with a 5-fluorouracil-containing regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Makati City, Philippines
        • Medical City
      • Manila, Philippines
        • Philippine General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Is between the ages of 18 and 75 years old, inclusive;
  2. Has a recurrent or progressive carcinoma of the colon or rectum with documented histological confirmation of primary carcinoma;
  3. Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST;
  4. Has previously received treatment with 5-FU, alone or in combination with other anti-tumor medications (except as in exclusion #1 below); Prior treatment with capecitabine (Xeloda®) will be considered to fulfill the requirement for prior treatment with 5-FU;
  5. Has a Karnofsky Score of ≥ 70;
  6. Has a life expectancy of > 3 months;

  7. Has adequate bone marrow reserve as evidenced by:

    1. ANC ≥ 1,500/μL
    2. PLT ≥ 100,000/μL
    3. HGB ≥ 9 g/dl;
  8. Has adequate renal function as evidenced by serum creatinine ≤ 1.5X the upper limit of normal (ULN) for the reference lab;

  9. Has adequate hepatic function as evidenced by:

    1. Serum total bilirubin ≤ 1.0 mg/dL
    2. AST ≤ 3X ULN for the reference lab (≤ 5X ULN for patients with known hepatic metastases)
    3. ALT ≤ 3X ULN for the reference lab (≤ 5X ULN for patients with known hepatic metastases);
  10. Has discontinued any CYP3A4 enzyme-inducing anticonvulsants (such as phenytoin, phenobarbital or carbamazepine) and antimicrobials (such as refampin and rifabutin), St. John's Wort, and ketoconasole at least two weeks prior to Day 1
  11. Has recovered from the effects of any prior surgery, radiotherapy, or chemotherapy;
  12. Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC); and
  13. If a woman of childbearing potential or a fertile man (and his partners), must agree to use an effective form of contraception during the study and for 120 days following the last dose of study medication (an effective form of contraception is an hormonal contraceptive or a double-barrier method).

Exclusion Criteria:

  1. Has previously received treatment with cetuximab or irinotecan;
  2. Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab;
  3. Has a hereditary fructose intolerance;
  4. Has a known hypersensitivity to baker's yeast, or has an active yeast infection;
  5. Has had previous exposure to Betafectin® or Imprime PGG;
  6. Has received previous radiation therapy to >30% of active bone marrow;
  7. Has a fever of >38.5º C within 3 days prior to initial dosing;
  8. Has known or suspected central nervous system (CNS) metastases;
  9. Had a second malignancy within the previous 5 years, except for basal cell carcinoma, cervical intra-epithelial neoplasia or curatively-treated prostate cancer with a PSA of < 2.0 ng/mL;
  10. Has known HIV/AIDS, Hepatitis B, Hepatitis C, connective tissue or autoimmune disease, or other clinical diagnosis, ongoing or intercurrent illness that in the investigator's opinion would prevent participation;
  11. If female, is pregnant or breast-feeding;
  12. Is receiving concurrent investigational therapy or has received investigational therapy within a period of 30 days prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory-authority-approved indication); or
  13. Has previously received an organ or progenitor/stem cell transplant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1, Cohort 1
2.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan.
Biological: Safety and efficacy of escalating doses
Imprime PGG and Cetuximab on Day 1 of each week for 6 weeks (one cycle) and irinotecan on Day 1 of each week for 4 weeks with a 2-week rest. Number of Cycles: until progression or unacceptable toxicity develops.
Experimental: Arm 1, Cohort 2
4.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan.
Biological: Safety and efficacy of escalating doses
Imprime PGG and Cetuximab on Day 1 of each week for 6 weeks (one cycle) and irinotecan on Day 1 of each week for 4 weeks with a 2-week rest. Number of Cycles: until progression or unacceptable toxicity develops.
Experimental: Arm 1, Cohort 3
6.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan.
Biological: Safety and efficacy of escalating doses
Imprime PGG and Cetuximab on Day 1 of each week for 6 weeks (one cycle) and irinotecan on Day 1 of each week for 4 weeks with a 2-week rest. Number of Cycles: until progression or unacceptable toxicity develops.
Experimental: Arm 2, Cohort 1
2.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab.
Biological: Safety and efficacy of escalating doses.
Imprime PGG and Cetuximab on Day 1 of each week for 6 weeks (one cycle). Number of Cycles: until progression or unacceptable toxicity develops.
Experimental: Arm 2, Cohort 2
4.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab.
Biological: Safety and efficacy of escalating doses.
Imprime PGG and Cetuximab on Day 1 of each week for 6 weeks (one cycle). Number of Cycles: until progression or unacceptable toxicity develops.
Experimental: Arm 2, Cohort 3
6.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab.
Biological: Safety and efficacy of escalating doses.
Imprime PGG and Cetuximab on Day 1 of each week for 6 weeks (one cycle). Number of Cycles: until progression or unacceptable toxicity develops.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine safety and maximum tolerated dosage of Imprime PGGwhen used in combination with cetuximab with and without irinotecan therapy in patients with recurrent/progressive colorectal carcinoma previously treated with a 5-FU regimen.
Time Frame: Prospective
Prospective

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the pharmacokinetic (PK) profile of Imprime PGG administered in combination with cetuximab with concomitant irinotecan therapy in patients with colorectal cancer.
Time Frame: Prospective
Prospective
To determine the tumor response rates (complete response, partial response, stable disease, overall response rate), time to progression, duration of overall tumor response, and the duration of stable disease in patients receiving the combination therapy.
Time Frame: Prospective
Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HiberCell, Inc.

Investigators

  • Principal Investigator: Ma. Belen Tamayo, MD, The Medical City Hospital
  • Principal Investigator: Gerardo Cornelio, MD, FPCP/FPS, Philippines General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 16, 2007

First Submitted That Met QC Criteria

October 16, 2007

First Posted (Estimate)

October 17, 2007

Study Record Updates

Last Update Posted (Estimate)

March 31, 2010

Last Update Submitted That Met QC Criteria

March 30, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BT-CL-PGG-CRC0713

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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