A Trial of Dalotuzumab in Combination With Irinotecan Versus Cetuximab and Irinotecan for Participants With Metastatic Rectal Cancers (mRC) (MK-0646-025 AM4)
This study has suspended participant recruitment.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01609231
First received: May 29, 2012
Last updated: May 9, 2013
Last verified: May 2013
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Purpose
The purpose of this adaptive trial is to compare the progression-free survival of participants with metastatic rectal carcinoma when treated with dalotuzumab + irinotecan therapy relative to participants treated with cetuximab + irinotecan.
| Condition | Intervention | Phase |
|---|---|---|
|
Rectal Neoplasms |
Drug: Dalotuzumab Drug: Irinotecan Drug: Cetuximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase IIA Open Label, Adaptive, Randomized Clinical Trial of Dalotuzumab (MK-0646) Treatment in Combination With Irinotecan Versus Cetuximab and Irinotecan for Patients With Metastatic Rectal Cancers (mRC) Expressing High IGF-1/Low IGF-2 Levels |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Progression-Free Survival (PFS) [ Time Frame: From randomization (Cycle 1 Day 1) to the first documented disease progression or death due to any cause, whichever occurs first (up to approximately 3 years) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective Response Rate [ Time Frame: From randomization (Cycle 1 Day 1) to the first documented disease progression or death due to any cause, whichever occurs first (up to approximately 3 years) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm A: Dalotuzumab + Irinotecan |
Drug: Dalotuzumab
Dalotuzumab will be administered intravenously after the completion of irinotecan infusion at a dose of 10 mg/kg once weekly.
Other Name: MK-0646
Drug: 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, such as with dexamethasone or atropine will follow local, or country-specific standard of care.
Other Name: Camptosar
|
| Active Comparator: Arm B: Cetuximab + Irinotecan |
Drug: 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, such as with dexamethasone or atropine will follow local, or country-specific standard of care.
Other Name: Camptosar
Drug: 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, such as with a histamine receptor antagonist or corticosteroid, will follow local, or country-specific standard of care.
Other Name: Erbitux
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Metastatic colorectal cancer with primary tumor originating from the rectum
- Available archival (recent or remote) tumor, or newly obtained formalin-fixed tissue available for analysis for biomarker studies
- 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
- Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Exclusion Criteria:
- Known diabetic who is poorly controlled
- 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
- Radiotherapy within 2 weeks prior to initial dosing on this study, unless the radiotherapy was for management of pain
- 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
- Could not complete previous course of irinotecan due to intolerable toxicity, other than discontinuation due to fatigue following prolonged administration (>4 months exposure)
- Prior exposure to insulin-like growth factor 1 receptor (IGF-1R) inhibitors or epidermal growth factor receptor (EGFR) inhibitors
- Known Central Nervous System (CNS) metastases and/or carcinomatous meningitis
- Primary CNS tumor
- 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.
- Human Immunodeficiency Virus (HIV)-positive
- Active Hepatitis B or C receiving antiviral treatment regimens
- Symptomatic ascites or pleural effusion
- Concurrently using growth hormone (GH), or growth hormone inhibitors
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609231
Locations
| United States, California | |
| Call for Information (Investigational Site 0044) | |
| Los Angeles, California, United States, 90033 | |
| United States, Kansas | |
| Call for Information (Investigational Site 0015) | |
| Wichita, Kansas, United States, 67214 | |
| United States, New Jersey | |
| Call for Information (Investigational Site 0012) | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, North Carolina | |
| Call for Information (Investigational Site 0011) | |
| Chapel Hill, North Carolina, United States, 27514 | |
| United States, Tennessee | |
| Call for Information (Investigational Site 0016) | |
| Nashville, Tennessee, United States, 37232 | |
| Belgium | |
| MSD Belgium BVBA/SPRL | |
| Brussels, Belgium | |
| Chile | |
| Merck Sharp & Dohme (I.A.) Corp. | |
| Santiago, Chile | |
| Denmark | |
| Merck Sharp & Dohme | |
| Glostrup, Denmark | |
| Korea, Republic of | |
| MSD Korea LTD | |
| Seoul, Korea, Republic of | |
| New Zealand | |
| Merck Sharp & Dohme (New Zealand) Ltd., | |
| Wellington, New Zealand | |
| Norway | |
| MSD Norge A/S | |
| Drammen, Norway | |
| Russian Federation | |
| Merck Sharp & Dohme IDEA, Inc. | |
| Moscow, Russian Federation | |
| Spain | |
| Merck Sharp and Dohme de Espana S.A. | |
| Madrid, Spain | |
| Sweden | |
| MSD | |
| Sollentuna, Sweden | |
| United Kingdom | |
| Merck Sharp & Dohme Ltd. | |
| Hoddesdon, United Kingdom | |
Sponsors and Collaborators
Merck
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01609231 History of Changes |
| Other Study ID Numbers: | 0646-025, 2012-000317-36 |
| Study First Received: | May 29, 2012 |
| Last Updated: | May 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Irinotecan Cetuximab |
Antibodies, Monoclonal Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunologic Factors |
ClinicalTrials.gov processed this record on May 22, 2013