Phase II Study to Evaluate G17DT in Combination With Irinotecan in Patients With Colorectal Carcinoma (CC6)

Cancer Advances

Status and phase

Completed

Phase 2

Conditions

Colorectal Cancer

Treatments

Biological: G17DT-Irinotecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT02118064

CC6

Details and patient eligibility

About

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.

Enrollment

161 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
Use contraceptive methods, if sexually active
Have the ability to understand the requirements of the study, to provide written informed consent, agree to abide by the study restrictions, and agree to return for the required assessments

Exclusion criteria

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
Use in the past 14 days or chronic concomitant use of proton pump inhibitors
Have uncontrolled serious cardiovascular or metabolic disease or any other uncontrolled serious medical or psychiatric illness
Have any condition that is likely to detrimentally affect regular follow up