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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00545545
• Date of registration: 16/10/2007
• Primary sponsor: Biothera
• Public title: Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma
• Scientific title: 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.
• Date of first enrolment: October 2007
• Target sample size: 48
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00545545
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Philippines

Contacts

• Name: Gerardo Cornelio, MD, FPCP/FPS
• Affiliation: Philippines General Hospital

• Name: Ma. Belen Tamayo, MD
• Affiliation: The Medical City Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Progressive Colorectal Carcinoma

Recurrent Colorectal Carcinoma

Intervention(s)

Biological: Safety and efficacy of escalating doses

Biological: Safety and efficacy of escalating doses.

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

Secondary ID(s)

BT-CL-PGG-CRC0713

Source(s) of Monetary Support

Please refer to primary and secondary sponsors