Adjuvant Aflibercept for Metastatic Colorectal Cancer

NCT01669720 | Terminated Phase 2 Results DMC

• 1 other identifier: BrUOG C261
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

The main purpose of this study is to evaluate if aflibercept can reduce the chance that metastatic (spread of) colorectal cancer can grow back after finishing standard treatment. The study will also look at the side effects of aflibercept and the effect on quality of life.

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic; Colorectal; Colorectal Cancer; Resected or Ablated Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Progressed

  Disease free survival in patients with advanced colorectal cancer who have undergone resection/ablation of all metastatic sites.

  Every 3 months until disease progression (for up to 2 years).

Secondary Outcomes (1)

• Number of Participants Who Experienced a Toxicity Profile of Adjuvant Ziv-aflibercept, up to 2-years of Duration, for Patients Who Previously Received Systemic Perioperative Therapy (Regimen) and Surgical Resection/Ablation.

  Throughout study treatment until 30 days post off study, approximately 2 years

Study Arms (2)

Aflibercept

EXPERIMENTAL

Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years

Drug: Aflibercept

Observation

NO INTERVENTION

Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.

Interventions

Aflibercept DRUG

Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years

Aflibercept

Eligibility Criteria

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

You may qualify if:

• First-line treatment of metastatic colorectal cancer with 3 or more metastases 3.1.2At least 10 cycles of combination therapy with an oxaliplatin or irinotecan based regimen per institutional preference (patients may receive 6 cycles, go to surgery, then complete 4 cycles, they may complete all 10 (or more) prior to surgery, or receive any combination as long as they receive at least 10 cycles. ) 3.1.3 Resection or ablation of all metastatic sites that have not achieved complete response with perioperative therapy (regimen). The sequencing of resection, ablation, and 10-12 cycles of combination therapy (regimen) with an oxaliplatin or irinotecan based regimen may be performed according to standard institutional procedure.
• Patients achieving a complete response in a metastatic site by stereotactic body radiation are eligible if the site was not easily accessible by surgery or ablation and a complete response was achieved.
• No severe, uncontrolled concurrent illness that would interfere with protocol therapy.
• No known CNS disease 3.1.7 ECOG Performance Status 0-2 3.1.8 No chemotherapy or radiation therapy within last 3 weeks 3.1.9 For patients who had 3 months of perioperative therapy (regimen), then surgery, then 3 months of therapy (regimen), patients must be off therapy for no more than 8 weeks prior to randomization. For patients who had all their therapy and then surgery, they must be no more than 8 weeks from surgery prior to randomization.
• No concurrent anticancer therapy. 3.1.11 Absolute neutrophil count ≥ 1,500/uL, Hgb \> 9.0 g/dl, platelet ≥ 100,000/uL.
• Total bilirubin ≤ 1.5x upper limit of normal (ULN) and AST or ALT ≤ 5x ULN; 3.1.13 Creatinine \< 1.5 x ULN 3.1.14 Life expectancy of at least 12 weeks. 3.1.15 Age ≥ 18 years 3.1.16 Women of childbearing potential must have a negative pregnancy test. 3.1.17 Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
• Voluntary written informed consent.

You may not qualify if:

• Residual metastatic disease after resection/ablation 3.2.2 Clinically significant cardiac disease (e.g., uncontrolled hypertension \[blood pressure of \>160/90 mmHg on medication\], history of myocardial infarction within 6 months,), New York Heart Association (NYHA) Class II or greater congestive heart failure within 6 months, unstable arrhythmia. Patients with an atrial arrhythmia must have this condition well controlled on stable medication. Patients with current or recent (within 6 months) unstable angina are also not eligible. Documentation of cardiac medical history to be provided.
• Significant bleeding diathesis or coagulopathy 3.2.4 History of cerebral aneurysms or cerebral arteriovenous malformations. 3.2.5 Patients with recent (within 12 months) arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), or clinically significant peripheral artery disease should also be excluded.
• Patients with a history of a gastrointestinal fistula or perforation. 3.2.7 Women who are breast-feeding. 3.2.8 Patients who have undergone major surgery, chemotherapy, or radiotherapy within the last 3 weeks.
• Patients on concurrent anticancer therapy.

Sponsors & Collaborators

• The Miriam Hospital: collaborator
• Brown University: lead
• Rhode Island Hospital: collaborator
• Lifespan: collaborator
• University of California, San Diego: collaborator
• Montefiore Medical Center: collaborator
• University of Florida: collaborator
• Sanofi: collaborator

Study Sites (2)

Rhode Island Hospital (East Greenwich and Newport)

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

aflibercept

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Howard Safran, MD
• Organization: Brown University Oncology Research Group (BrUOG)

kayla_rosati@brown.edu

4018633000

Study Officials

• Howard Safran, MD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 21, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: February 17, 2020
• Results First Posted: March 10, 2016

Record last verified: 2020-02

Locations

US (2)