Phase II Study to Evaluate G17DT in Combination With Irinotecan in Patients With Colorectal Carcinoma

NCT02118064 | Completed Phase 2

• 1 other identifier: CC6
• Study Type: interventional
• Target: 161
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was designed to evaluate the ability for G17DT to slow or arrest tumor growth in patients with refractory colon cancer who had been previously treated with an Irinotecan-based chemotherapy.

Conditions

Colorectal Cancer

Keywords

G17DT; irinotecan; Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• Tumor response

  Evaluate the effect of G17DT-Irinotecan combination therapy on tumor response assessed by magnetic resonance imaging or computed tomography.

  up to 12 months

• Survival time

  The vital status of patients was monitored until death or end of the study.

  up to 12 months

• Number of Patients with Serious and Non-Serious Adverse Events

  Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-existing illnesses, were assessed at each visit.

  Up to 12 months

Study Arms (1)

G17DT-Irinotecan

EXPERIMENTAL

500µg dose of G17DT intramuscular injection in combination with 125 mg/m\^2 intravenous infusion of Irinotecan over 90 minutes.

Biological: G17DT-Irinotecan

Interventions

G17DT-Irinotecan BIOLOGICAL

500µg dose of G17DT intramuscular injection in combination with 125 mg/m\^2 intravenous infusion of Irinotecan over 90 minutes.

G17DT-Irinotecan

Eligibility Criteria

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

You may qualify if:

• Have histologically confirmed cancer of the colon or rectum or both and objective evidence of distant metastases
• Have measurable disease
• Have previously been treated with an irinotecan based chemotherapy
• Have progressive metastatic disease after an irinotecan containing chemotherapy regimen (alone or in combination) for metastatic colorectal cancer
• Be at least 18 years of age
• Have laboratory data as specified below:
• Aspartate aminotransferase (AST) and ALT less than 2.5 times upper limit of normal
• Bilirubin less than 1.5 mg/dL (SI units, 25.65 mol/L)
• Creatinine less than 1.5 mg/dL (SI units, 132 mol/L)
• White blood cell (WBC) count greater than 3,000/mm3
• Platelets greater than 100,000/mm3
• Hemoglobin more than 9.5 g/dL (SI units, 5.9 mol/L)
• International normalized ratio of prothrombin time less than 1.2, and activated partial thromboplastin time no more than 5 seconds above normal limits
• Have a life expectancy of at least 3 months
• Have a KPS score of 70 or greater

You may not qualify if:

• Be pregnant or nursing
• Have only symptomatic locally recurrent colorectal cancer
• Have had any active cancer in addition to metastatic colorectal cancer within the last 5 years except curatively treated nonmelanomatous skin cancer
• Have received any prior anticancer immunotherapy
• Have central nervous system metastasis, whether treated or not
• Have bone metastases as sole manifestation of metastatic colorectal cancer
• Have received chemotherapy within the previous 21 days
• Have had major surgery within 21 days
• Have immunodeficiency (primary or acquired)
• Have undergone bone marrow transplantation within the last year
• Require chronic administration of corticosteroids; inhaled corticosteroids for asthma and chronic obstructive pulmonary disease are allowed
• Use in the past 30 days or concomitant use of immunosuppressants, including systemic (i.e., oral or injected) corticosteroids
• Have participated in any clinical trial involving conventional or investigational drugs or devices within 21 days before G17DT irinotecan administration
• Have contraindication to irinotecan based therapy
• Have hypersensitivity to diphtheria toxoid

Sponsors & Collaborators

• Cancer Advances Inc.: lead

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: March 1, 2001
• Primary Completion: December 1, 2002
• Last Updated: April 21, 2014

Record last verified: 2014-01