Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma
This study has been completed.
Sponsor:
Biothera
Information provided by:
Biothera
ClinicalTrials.gov Identifier:
NCT00545545
First received: October 16, 2007
Last updated: March 30, 2010
Last verified: March 2010
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Purpose
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.
Condition | Intervention | Phase |
---|---|---|
Recurrent Colorectal Carcinoma Progressive Colorectal Carcinoma |
Biological: Safety and efficacy of escalating doses Biological: Safety and efficacy of escalating doses. |
Phase 1 Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official 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. |
Resource links provided by NLM:
Further study details as provided by Biothera:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Estimated Enrollment: | 48 |
Study Start Date: | October 2007 |
Study Completion Date: | December 2009 |
Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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.
|
Eligibility
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Is between the ages of 18 and 75 years old, inclusive;
- Has a recurrent or progressive carcinoma of the colon or rectum with documented histological confirmation of primary carcinoma;
- Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST;
- 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;
- Has a Karnofsky Score of ≥ 70;
- Has a life expectancy of > 3 months;
Has adequate bone marrow reserve as evidenced by:
- ANC ≥ 1,500/μL
- PLT ≥ 100,000/μL
- HGB ≥ 9 g/dl;
- Has adequate renal function as evidenced by serum creatinine ≤ 1.5X the upper limit of normal (ULN) for the reference lab;
Has adequate hepatic function as evidenced by:
- Serum total bilirubin ≤ 1.0 mg/dL
- AST ≤ 3X ULN for the reference lab (≤ 5X ULN for patients with known hepatic metastases)
- ALT ≤ 3X ULN for the reference lab (≤ 5X ULN for patients with known hepatic metastases);
- 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
- Has recovered from the effects of any prior surgery, radiotherapy, or chemotherapy;
- Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC); and
- 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:
- Has previously received treatment with cetuximab or irinotecan;
- Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab;
- Has a hereditary fructose intolerance;
- Has a known hypersensitivity to baker's yeast, or has an active yeast infection;
- Has had previous exposure to Betafectin® or Imprime PGG;
- Has received previous radiation therapy to >30% of active bone marrow;
- Has a fever of >38.5º C within 3 days prior to initial dosing;
- Has known or suspected central nervous system (CNS) metastases;
- 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;
- 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;
- If female, is pregnant or breast-feeding;
- 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
- Has previously received an organ or progenitor/stem cell transplant.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545545
Locations
Philippines | |
Medical City | |
Makati City, Philippines | |
Philippine General Hospital | |
Manila, Philippines |
Sponsors and Collaborators
Biothera
Investigators
Principal Investigator: | Ma. Belen Tamayo, MD | The Medical City Hospital |
Principal Investigator: | Gerardo Cornelio, MD, FPCP/FPS | Philippines General Hospital |
More Information
No publications provided
Keywords provided by Biothera:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
No publications provided
Responsible Party: | Michele Gargano, VP Clinical Development, Biothera |
ClinicalTrials.gov Identifier: | NCT00545545 History of Changes |
Other Study ID Numbers: | BT-CL-PGG-CRC0713 |
Study First Received: | October 16, 2007 |
Last Updated: | March 30, 2010 |
Health Authority: | Philippines: Bureau of Food and Drugs |
Keywords provided by Biothera:
Colorectal Carcinoma Recurrent Progressive |
Cetuximab Irinotecan 5-Fluorouracil |
Additional relevant MeSH terms:
Carcinoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Irinotecan Cetuximab Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 17, 2012