Efficacy and Safety Study of Imprime PGG With Cetuximab in Subjects With Stage IV KRAS-Mutated Colorectal Cancer

NCT00912327 | Completed DMC

• 1 other identifier: BT-CL-PGG-CRC0821
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

Study BT-CL-PGG-CRC0821 is a Phase 2, open-label, multicenter, efficacy and safety study. It will be conducted using a two-stage design with the intention of determining the initial efficacy of Imprime PGG in combination with a monoclonal antibody (MAb; cetuximab) in the treatment of KRAS-mutant colorectal cancer (CRC). Both stages will be conducted in subjects with Stage IV CRC demonstrating the KRAS gene mutation. Subjects will dose until progression of disease or discontinuation from the study for other reasons; e.g., safety, non-compliance. Approximately 56 subjects will be enrolled at three participating centers (17 into Stage 1 and 39 into Stage 2).

Conditions

Colorectal Cancer

Keywords

Colorectal; KRAS mutation; Stage IV; Imprime PGG; Cetuximab; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Assessed after 17 subjects complete 1 treatment cycle and at completion of study.

Secondary Outcomes (8)

• Disease control rate (DCR) and duration of disease control

  Assessed after 17 subjects complete 1 treatment cycle and at completion of study.

• Complete response (CR), partial response (PR), and stable disease (SD) rates

  Assessed after 17 subjects complete 1 treatment cycle and at completion of study.

• Duration of objective tumor response

  Assessed after 17 subjects complete 1 treatment cycle and at completion of study.

• Duration of stable disease

  Assessed after 17 subjects complete 1 treatment cycle and at completion of study.

• Time to progression (TTP)

  Assessed after 17 subjects complete 1 treatment cycle and at completion of study.

Study Arms (2)

Stage 1

Biological: Imprime PGG

Stage 2

Biological: Imprime PGG

Interventions

Imprime PGG BIOLOGICAL

Imprime PGG, 4 mg/kg, i.v. over 2 hr, weekly in 6 week cycles and Cetuximab, initial dose will be 400 mg/m2 via i.v., and subsequent doses will be 250 mg/m2 via i.v., weekly in 6 week cycles

Also known as: Erbitux

Stage 1; Stage 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Approximately 56 patients with Stage IV Kras-mutated colorectal cancer.

You may qualify if:

• Is \>18 years old;
• Has Stage IV carcinoma of the colon or rectum with documented histological or cytological confirmation;
• Tumor has known KRAS mutation;
• Has failed previous irinotecan- and oxaliplatin-containing regimens in either adjuvant or metastatic settings or is intolerant to irinotecan-based therapies;
• Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST;
• Has not received any other treatment for colorectal cancer within the 30 days prior to first dose of study treatment under this protocol;
• Has an ECOG score of 0-1;
• Has a life expectancy of \> 3 months;
• Has adequate bone marrow reserve as evidenced by:
• ANC ≥ 1,500/μL
• PLT ≥ 100,000/μL
• Has adequate renal function as evidenced by serum creatinine ≤ 2.5X the upper limit of normal (ULN) for the reference lab;
• Has adequate hepatic function as evidenced by:
• AST ≤ 3X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases)
• ALT ≤ 3X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases)

You may not qualify if:

• Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab;
• Has a known hypersensitivity to baker's yeast or has an active yeast infection;
• Has had previous exposure to Betafectin® or Imprime PGG;
• Has an active, uncontrolled infection;
• Has known or suspected brain 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 disease, or other clinical diagnosis, ongoing or intercurrent illness that in the investigator's opinion should prevent participation;
• If female, is pregnant or breast-feeding;
• Is receiving concurrent standard and/or investigational anti-cancer therapy or has received such 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.

Sponsors & Collaborators

• HiberCell, Inc.: lead

Study Sites (3)

University of Minnesota

Minneapolis, Minnesota, United States

Location

Memorial Sloane-Kettering Cancer Research Center

New York, New York, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue samples from previous biopsies and blood plasma will be collected.

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Leonard Saltz, MD

  Memorial Sloane-Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Neil H. Segal, MD, PhD

  Memorial Sloane-Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Neil Senzer, MD

  Mary Crowley Medical Research Center

  PRINCIPAL INVESTIGATOR

• Purvi Gada, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Study Start: June 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 15, 2012

Record last verified: 2012-02

Locations

US (3)