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Recurrent Colon CancerNCT01941173

Short-Infusion Ziv-aflibercept in Treating Patients With Metastatic Colorectal Cancer Receiving Combination Chemotherapy

A study testing ziv-aflibercept, leucovorin calcium and irinotecan hydrochloride in people with Recurrent Colon Cancer and Recurrent Rectal Cancer, run by City of Hope Medical Center at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ziv-aflibercept, leucovorin calcium and irinotecan hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesUnited States
Study dates
Jan 2014to Jul 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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
  • All subjects must have the ability to understand and the willingness to sign a written consent

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • City of Hope Medical Center

    Duarte, California, 91010

  • City of Hope Antelope Valley

    Lancaster, California, 93534

  • City of Hope- South Pasadena Cancer Center

    South Pasadena, California, 91030

Other trials in United States

About this study

Official title: A Prospective Study of Short Infusion of Ziv-Aflibercept in Combination With FOLFIRI in Patients With Metastatic Colorectal Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the feasibility of a shorter infusion of 30 minutes and 15 minutes of standard dose ziv-aflibercept when combined with FOLFIRI (folinic acid [leucovorin calcium], fluorouracil, and irinotecan [irinotecan hydrochloride]) in patients with metastatic colorectal cancer.

SECONDARY OBJECTIVES:

  1. Describe the institutional safety experience with this combination using Common Terminology Criteria for Adverse Events (CTCAE) version 4 for toxicity grading.

OUTLINE:

Patients receive ziv-aflibercept intravenously (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.

After completion of study treatment, patients are followed up for 30 days.

Medical subject headings
Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ziv-afliberceptBiological

    Also called aflibercept, vascular endothelial growth factor trap, VEGF Trap, Zaltrap

    Given IV

  • leucovorin calciumDrug

    Also called CF, CFR, LV

    Given IV

  • irinotecan hydrochlorideDrug

    Also called Campto, Camptosar, CPT-11, irinotecan

    Given IV

  • fluorouracilDrug

    Also called 5-fluorouracil, 5-Fluracil, 5-FU

    Given IV

Study groups in NCT01941173
Study groupRoleWhat they receive
Treatment (ziv-aflibercept, FOLFIRI)ExperimentalPatients 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.
Receives: Biological: ziv-aflibercept; Drug: leucovorin calcium; Drug: irinotecan hydrochloride; Drug: fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 30 days after last study treatment

Secondary outcomes (1)

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

    Upon completion of the study, toxicity will be summarized and tabulated.

    Measured: Up to 30 days after last study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionJul 2014

Why it stopped: Lack of accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01941173
Sponsor's protocol ID
13294
Other IDs
NCI-2013-01727, 13294
Status last verified
Jul 2014
First submitted
9 Sep 2013
Last updated
21 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing ziv-aflibercept, leucovorin calcium and irinotecan hydrochloride in people with Recurrent Colon Cancer and Recurrent Rectal Cancer, run by City of Hope Medical Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Up to 30 days after last study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01941173.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2014.

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