NCT01941173

Brief Summary

This pilot clinical trial studies short-infusion ziv-aflibercept in treating patients with metastatic colorectal cancer receiving combination chemotherapy. Ziv-aflibercept may stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving the drug over a shorter infusion time may result in improved efficiency and patient satisfaction.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

July 21, 2014

Status Verified

July 1, 2014

Enrollment Period

6 months

First QC Date

September 9, 2013

Last Update Submit

July 17, 2014

Conditions

Recurrent Colon CancerRecurrent Rectal CancerStage IVA Colon CancerStage IVA Rectal CancerStage IVB Colon CancerStage IVB Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Feasibility of a shorter infusion time, determined by rate of greater or equal to grade 2 hypersensitivity reactions as graded according to CTCAE version 4.0

    All hypersensitivity grades will be collected (including grade 1). Upon completion of the study, toxicity will be summarized and tabulated.

    Up to 30 days after last study treatment

Secondary Outcomes (1)

  • Incidence of grade 3 and above toxicities, graded according to CTCAE version 4.0

    Up to 30 days after last study treatment

Other Outcomes (1)

  • Time on protocol therapy

    Up to 30 days after last study treatment

Study Arms (1)

Treatment (ziv-aflibercept, FOLFIRI)

EXPERIMENTAL

Patients receive ziv-aflibercept IV over 15-30 minutes followed by FOLFIFRI chemotherapy comprising leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV over 46 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

Biological: ziv-afliberceptDrug: leucovorin calciumDrug: irinotecan hydrochlorideDrug: fluorouracil

Interventions

ziv-afliberceptBIOLOGICAL

Given IV

Also known as: aflibercept, vascular endothelial growth factor trap, VEGF Trap, Zaltrap
Treatment (ziv-aflibercept, FOLFIRI)
leucovorin calciumDRUG

Given IV

Also known as: CF, CFR, LV
Treatment (ziv-aflibercept, FOLFIRI)
irinotecan hydrochlorideDRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E
Treatment (ziv-aflibercept, FOLFIRI)
fluorouracilDRUG

Given IV

Also known as: 5-fluorouracil, 5-Fluracil, 5-FU
Treatment (ziv-aflibercept, FOLFIRI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with metastatic colorectal cancer are eligible for this study; colorectal cancer should have been previously confirmed by pathology or cytology; to be eligible for this protocol, patients should be receiving ziv-aflibercept plus FOLFIRI as a standard treatment prior to enrolling on this trial; the number and type of therapy administered prior to enrollment will not affect the ability to enroll on this study
  • Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Patients should have an expected life expectancy of 12 weeks or longer
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
  • To be eligible for this study, patients should already be receiving a standard dose of ziv-aflibercept intravenously over 60 minutes in combination with FOLFIRI chemotherapy every 2 weeks without evidence of progressive disease; treatment on this study can start as early as two weeks from last "off protocol" ziv-aflibercept plus FOLFIRI cycle, granted treatment parameters have been met
  • Total bilirubin \< 1.5 upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 ULN unless patient has metastatic disease to the liver in which case \< 5 ULN will be allowed
  • Serum creatinine \< 1.5 ULN
  • Urine protein/creatinine ration (UPCR) =\< 1 or total urinary protein of \< 1 gm/24 hours in the event the UPCR \> 1
  • Systolic blood pressure \< 155 mm mercury and diastolic blood pressure \< 100 mm mercury documented on two separate occasions at least 24 hours apart
  • Platelet counts \>= 75,000/mm\^3
  • Neutrophil count \>= 1500/mm\^3
  • Hemoglobin \>= 9 gm/dl; anemia can be corrected with transfusion to allow eligibility prior to enrollment
  • Hematological tests can be repeated to assess eligibility
  • No unresolved grade 2 or above non-hematological toxicities, with the exception of alopecia or neuropathy
  • +1 more criteria

You may not qualify if:

  • Patients should not have any uncontrolled illness such as congestive heart failure, respiratory distress, and including ongoing or active infection
  • Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy with the exception of study drugs
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ziv-aflibercept
  • Patients should be at least 2 weeks from their last dose of ziv-aflibercept when they receive their first dose of study treatment
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated on this study
  • Patients with other active malignancies are ineligible for this study with the exception of non-melanoma skin cancer that is amenable to excision, cervical carcinoma in situ, hormone sensitive prostate cancer, or prostate cancer with no measurable disease (watchful waiting)
  • History of arterial thrombotic events within 1 year prior to enrollment on study
  • Surgical intervention within 4 weeks prior to study initiation and no open wounds
  • Clinically significant bleeding; clinically significant bleeding is defined as gastrointestinal bleeding requiring a blood transfusion, bleeding manifesting as melena, or blood per rectum estimated to exceed 2 tablespoons within 4 weeks prior to enrollment; hemoptysis associated with blood loss of more than 1/2 tablespoon per day is also considered significant; physician judgment will be used to estimate presence or lack of significant clinical bleeding
  • History of bowel perforation
  • History of intracranial bleeding
  • History of reversible posterior leukoencephalopathy syndrome (RPLS)
  • History of active fistula
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope Antelope Valley

Lancaster, California, 93534, United States

Location

City of Hope- South Pasadena Cancer Center

South Pasadena, California, 91030, United States

Location

MeSH Terms

Conditions

Colonic NeoplasmsRectal Neoplasms

Interventions

afliberceptLeucovorinIrinotecanFluorouracil

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

FormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesCamptothecinAlkaloidsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Marwan Fakih

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 13, 2013

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Last Updated

July 21, 2014

Record last verified: 2014-07

Locations

US(3)