Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01609231
Other study ID # 0646-025
Secondary ID 2012-000317-36MK
Status Terminated
Phase Phase 2
First received
Last updated
Start date July 6, 2012
Est. completion date December 9, 2014

Study information

Verified date April 2020
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this adaptive trial is to compare the progression-free survival of participants with metastatic rectal carcinoma when treated with intravenous (IV) dalotuzumab (MK-0646) + irinotecan therapy relative to participants treated with IV cetuximab + irinotecan. The primary hypothesis is that administration of dalotuzumab in combination with irinotecan to participants with wild-type KRAS metastatic rectal carcinoma with high insulin growth factor (IGF)-1/low IGF-2 expression levels improves progression-free survival compared to patients treated with cetuximab in combination with irinotecan.


Recruitment information / eligibility

Status Terminated
Enrollment 11
Est. completion date December 9, 2014
Est. primary completion date December 9, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Has metastatic colorectal cancer with primary tumor originating from the rectum

- Has an available archival (recent or remote) tumor, or newly obtained formalin-fixed tissue available for analysis for biomarker studies

- Has at least one measurable lesion greater than or equal to 10 mm

- Disease has progressed after treatment with both irinotecan- and oxaliplatin-containing regimens and should have progressed on or within 3 months of completing their last line of therapy

- Has a performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale

Exclusion Criteria:

- Has poorly-controlled diabetes

- Has received chemotherapy or biological therapy within 2 weeks prior to initial dosing on this study, or whose toxicities from agents administered 2 weeks earlier have not resolved to at least grade 1 or baseline, or who is within 3 weeks from a prior surgery

- Has received radiotherapy within 2 weeks prior to initial dosing on this study, unless the radiotherapy was for management of pain

- Is currently participating or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the investigational agent, whichever is longer, of initial dosing on this study

- Was unable to complete previous course of irinotecan due to intolerable toxicity, other than discontinuation due to fatigue following prolonged administration (>4 months exposure)

- Has prior exposure to insulin-like growth factor 1 receptor (IGF-1R) inhibitors or epidermal growth factor receptor (EGFR) inhibitors

- Has a known central nervous system (CNS) metastases and/or carcinomatous meningitis

- Has primary CNS tumor

- Has a history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma; potentially curative therapy with no evidence of that disease for 5 years, deemed low risk for recurrence by treating physician.

- Is human immunodeficiency virus (HIV)-positive

- Has active hepatitis B or C infection and is receiving antiviral treatment regimens

- Has symptomatic ascites or pleural effusion

- Is concurrently using growth hormone (GH), or growth hormone inhibitors

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dalotuzumab
Dalotuzumab will be administered intravenously after the completion of irinotecan infusion at a dose of 10 mg/kg once weekly.
Irinotecan
Irinotecan 180 mg/m^2 will be administered intravenously once every two weeks either prior to dalotuzumab (Arm A) or after cetuximab (Arm B). Pre-medication at the discretion of the investigator will follow local or country-specific standard of care.
Cetuximab
Cetuximab will be administered intravenously prior to irinotecan at an initial dose of 400 mg/m^2 followed by weekly infusions of 250 mg/m^2. Pre-medication at the discretion of the investigator will follow local or country-specific standard of care.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of Progression-free Survival (PFS) PFS is a measure of the time from randomization to the time of first documented disease progression (assessed by an independent Radiology Review Committee [iRRC]) or participant death, whichever occurs first. From randomization (Cycle 1, Day 1) to the first documented disease progression or death due to any cause, whichever occurs first (up to 3 years)
Secondary Percentage of Participants With Objective Response Rate (ORR) ORR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) during the course of the study using enhanced Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Confirmation of response was not required. From randomization (Cycle 1, Day 1) to the first documented disease progression or death due to any cause, whichever occurs first (up to 3 years)
See also
  Status Clinical Trial Phase
Completed NCT02537340 - PET/MR for Staging Rectal Cancer Patients With and Without EMVI-MR
Recruiting NCT02565667 - A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler N/A
Terminated NCT02538913 - Exercise Training for Rectal Cancer Patients N/A
Not yet recruiting NCT02439086 - Prediction of Response to Neoadjuvant Therapy in Rectal Cancer N/A
Completed NCT02233374 - Predicting RadIotherapy ReSponse of Rectal Cancer With MRI and PET N/A
Completed NCT00535652 - Concentration of Ertapenem in Colorectal Tissue Phase 4
Completed NCT00535041 - Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA N/A
Recruiting NCT04949646 - Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision N/A
Recruiting NCT04095468 - Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
Recruiting NCT06017583 - Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer Phase 3
Recruiting NCT05689775 - Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
Recruiting NCT04006951 - Development of a Clinical and Biological Database in Rectum Cancer N/A
Recruiting NCT05068180 - Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients Phase 4
Recruiting NCT03714490 - MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy for Unresectable Rectal Cancer Phase 2
Recruiting NCT03325361 - The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage N/A
Completed NCT02252250 - Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer N/A
Completed NCT04455737 - Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision
Completed NCT01816607 - Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
Completed NCT01721785 - Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer N/A
Active, not recruiting NCT01171300 - Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients N/A