Chemoembolization, Irinotecan Bead, Second Line Chemotherapy Treatment of Unresectable Metastatic Colorectal Cancer

NCT00816777 | Terminated Phase 1 Results FDA Drug FDA Device

• 2 other identifiers: CA1013IDE G070122
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in combination with intravenous chemotherapy versus intravenous chemotherapy alone in the treatment of unresectable liver metastases in patients with colorectal cancer. The results of this study are intended to be used in support of a PMA application for a combination device

Conditions

Unresectable Metastatic Colo-rectal Cancer

Keywords

Cancer; Carcinoma; Colon Cancer; Colorectal Cancer; Gastric Cancer; Gastrointestinal Cancer; Metastases; Metastatic Cancer; Metastatic Colorectal Cancer; Oncology; Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  1 year

Secondary Outcomes (7)

• Toxicity, Adverse Events and Serious Adverse Events (NCI CTCAE v3.0)

  6 weeks

• Tumor Response (RECIST)

  1 year

• Local Tumor Response (Extent of Necrosis in the Treated Lesions)

  1 year

• Hepatic Progression Free Survival

  1 year

• Change in Tumor Marker

  1 year

Study Arms (2)

Chemoembolization

EXPERIMENTAL

Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)

Procedure: Chemoembolization with irinotecan Bead; Drug: Irinotecan

Chemotherapy

ACTIVE COMPARATOR

Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Drug: Irinotecan

Interventions

Chemoembolization with irinotecan Bead PROCEDURE

Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule

Also known as: Trans arterial Chemoembolization, Irinotecan Bead

Chemoembolization

Irinotecan DRUG

Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Also known as: camptosar

Chemoembolization; Chemotherapy

Eligibility Criteria

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

You may qualify if:

• Patients with confirmed diagnosis of stage IV colorectal cancer with unresectable liver metastases (primary tumor may be present)
• Patients with at least one measurable liver metastases, with size \> 1cm (RECIST criteria)
• Patients with liver dominant disease defined as ≥50% tumor body burden confined to the liver
• Patients with patent main portal vein
• Performance status ≤ 2 ECOG
• Life expectancy \> 6 months
• Aged ≥18 years
• Patient has failed (discontinued for progression or toxicity) one prior line of chemotherapy for metastatic disease, preferably oxaliplatin-based (e.g. FOLFOX, CAPOX). Note that substitutions of oral versus IV 5-FU formulations, changes in 5-FU schedules, or discontinuations/re-starting of the same chemotherapy drugs will not be considered as separate lines of therapy, nor will the addition of "biologics" such as bevacizumab, cetuximab, or panitumumab
• Patient has no previous treatment with irinotecan
• At least 4 weeks since last administration of last chemotherapy and /or radiotherapy
• Hematologic function: ANC ≥ 1.5 x 109/L, platelets ≥75 x10-9/L, INR \<1.5 (patients on therapeutic anticoagulants are not eligible)
• Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl,
• Adequate renal function (creatinine ≤ 2.0mg/dl)
• Women of child bearing potential and fertile men are required to use effective contraception (negative serum βHCG/urine test for women of child-bearing age)
• Signed, written informed consent

You may not qualify if:

• Patient eligible for curative treatment (i.e. resection or radiofrequency ablation). Note: resectability is defined as a single tumor \<5cm with adequate liver function defined: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl
• Contraindications to irinotecan:
• Chronic inflammatory bowel disease and/or bowel obstruction
• History of severe hypersensitivity reactions to irinotecan hydrochloride trihydrate, lactic acid or to any of the excipients of Camptosar
• Severe bone marrow failure
• History of Gilbert Syndrome (specific testing not required)
• Concomitant use with St John's Wort (Hypericum)
• Active bacterial, viral or fungal infection within 72 hours of study entry
• Women who are pregnant or breast feeding
• Previous irinotecan based therapy for metastatic disease
• Patients' whose only measurable disease is within an area of the liver previously subject to radiotherapy
• Allergy to contrast media that cannot be managed with standard care (e.g. steroids)
• Presence of another malignancy with the exception of cervical carcinoma in situ and stage I basal or squamous carcinoma of the skin
• Contraindicated for MRI or CT
• Patients previously treated with transarterial embolization (with or without chemotherapy)

Sponsors & Collaborators

• Generic Devices Consulting, Inc.: lead
• Biocompatibles UK Ltd: collaborator

Study Sites (3)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

MeSH Terms

Conditions

Neoplasms; Carcinoma; Colonic Neoplasms; Colorectal Neoplasms; Stomach Neoplasms; Gastrointestinal Neoplasms; Neoplasm Metastasis; Rectal Neoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Intestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: John Greenbaum
• Organization: Generic Devices Consulting, Inc

genericd@bellsouth.net

772-353-5301

Study Officials

• Wells Messersmith, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2009
• First Posted: January 5, 2009
• Study Start: December 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 7, 2018
• Results First Posted: September 18, 2015

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)