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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 1/Phase 2
18 Years
75 Years
Not Enrolling
Both
Recurrent Colorectal Carcinoma, Progressive Colorectal Carcinoma

Thank you

Trial Information

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.


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.

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:

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.

Outcome Time Frame:

Prospective

Safety Issue:

No

Principal Investigator

Ma. Belen Tamayo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Medical City Hospital

Authority:

Philippines: Bureau of Food and Drugs

Study ID:

BT-CL-PGG-CRC0713

NCT ID:

NCT00545545

Start Date:

October 2007

Completion Date:

December 2009

Related Keywords:

  • Recurrent Colorectal Carcinoma
  • Progressive Colorectal Carcinoma
  • Colorectal
  • Carcinoma
  • Recurrent
  • Progressive
  • Cetuximab
  • Irinotecan
  • 5-Fluorouracil
  • Carcinoma
  • Colorectal Neoplasms

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