Metastatic Colorectal CancerPhase 2NCT02079220
A Phase II Study of Ziv-aflibercept in Combination With Capecitabine/Oxaliplatin (XELOX) Chemotherapy in the Front-Line Treatment of Patients With Metastatic Colorectal Cancer
A Phase 2 study testing Arm A and Arm B in people with Metastatic Colorectal Cancer, run by James J Lee at 1 site in United States.
Trial summary
This is an open label, two-arm, phase II trial to evaluate the anti-tumor activity, safety, and tolerability of ziv-aflibercept in combination with XELOX chemotherapy in the first-line treatment of subjects with mCRC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Arm A and Arm B
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2018
- Phase
- Phase 2
- 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
- The study will be limited to subjects with newly diagnosed mCRC without any prior systemic chemotherapy for metastatic disease.
- The diagnosis of metastatic colorectal cancer will be based on histologic or cytologic confirmation.
- Subjects must have the ability to swallow oral medication.
- Subjects must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan, MRI, or calipers by clinical exam.
- Any prior chemotherapy for mCRC is not allowed. Adjuvant chemotherapy with oxaliplatin-containing regimen CRC within the last 12 months is not allowed. Adjuvant chemotherapy with Fluorouracil (5-FU) or capecitabine alone within the last 6 months is allowed.
- Age ≥ 18 years.
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- Both men and women of all races and ethnic groups are eligible for this trial.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥ 60%).
- Life expectancy of greater than 12 months.
- Patients must have normal organ and marrow function as defined below:
- Absolute Neutrophil Count ≥ 1,500/mm3
- Platelets ≥ 100,000/mm3
- Total Bilirubin 2 × institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and Alanine transaminase (ALT) 2.5 × institutional upper limit of normal (AST and ALT ≤ 5.0 x ULN is acceptable if liver has tumor involvement).
- Creatinine Clearance (CrCl) 30 mL/min.
- The effects of the combination of ziv-aflibercept, oxaliplatin and capecitabine on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and 6 months after last administration of ziv-aflibercept. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of therapeutic agents administration and 6 months after last administration of ziv-aflibercept.
- Ability to understand and to sign a written informed consent document.
Who cannot join
- Unwilling or unable to follow protocol requirements or to give informed consent.
- Any prior chemotherapy for mCRC.
- Adjuvant chemotherapy with oxaliplatin-containing regimen CRC within the last 12 months.
- Adjuvant chemotherapy with 5-FU or capecitabine alone within the last 6 months is allowed.
- CrCl < 30 mL/min
- Any peripheral neuropathy of grade ≥ 2
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- Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency
- Patients with urine protein creatinine ration > 1 or urine protein > 500 mg/24 hours.
- Patients who have had radiotherapy within 4 weeks to entering the study or those who have not recovered from adverse events due to radiotherapy administered more than 4 weeks earlier.
- Patients with uncontrolled or symptomatic brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Presence of metastatic disease that, in the opinion of the investigator, would require palliative treatment within 4 weeks of enrollment.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because ziv-aflibercept, capecitabine, and oxaliplatin are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ziv-aflibercept, capecitabine, and oxaliplatin, breastfeeding should be discontinued if the mother is treated with ziv-aflibercept, capecitabine, and oxaliplatin.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ziv-aflibercept, capecitabine, and oxaliplatin. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
- Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease or condition significantly affecting gastrointestinal function.
- Serious or non-healing wound, skin ulcer, or bone fracture.
- History of bleeding diathesis or coagulopathy or active anticoagulation with Coumadin.
- Any documented stroke or Transient Ischemic Attack (TIA) within 6 months prior to study entry
- Any grade 3/4 hemorrhage within 3 months prior to study entry
- Any pulmonary embolism (PE) within 3 months prior to study entry
- Any deep vein thrombosis (DVT) within 3 months prior to study entry
- Uncontrolled hypertension defined as > 140/90 mmHg or isolated systolic hypertension > 160 mmHg on 2 separate days in past 3 months prior to study inclusion.
- Any of the following cardiac conditions:
- Documented congestive heart failure
- Myocardial infarction within 6 months prior to study entry
- Unstable angina within 6 months prior to study entry
- Symptomatic arrhythmia
Trial locations and contacts
1 site in 1 country.
United States1 site
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
This is an open label, two-arm, phase II trial to evaluate the anti-tumor activity, safety, and tolerability of ziv-aflibercept in combination with XELOX chemotherapy in the first-line treatment of subjects with mCRC.
Two different schedules of ziv-aflibercept in combination with XELOX will be evaluated in this study: every 2 week schedule (Arm A) and the every 3 week schedule (Arm B). The choice between arm A and arm B will depend on the investigator's preference.
Read more
Arm A (every 2 week schedule) Dosage and dosage regimen for all study periods
- Capecitabine: will be administered 1,000 mg/m2 orally twice a day on Days 1 - 7 of each cycle, repeating every 14 days.
- Oxaliplatin: will be administered 85 mg/m2 IV on Day 1 of each cycle, repeating every 14 days.
- Ziv-aflibercept: will be administered 4 mg/kg IV on Day 1 of each cycle, repeating every 14 days.
Arm B (every 3 week schedule):
Dosage and dosage regimen for all study periods
- Capecitabine: will be administered 850 mg/m2 orally twice a day on Days 1 - 14 of each cycle, repeating every 21 days.
- Oxaliplatin: will be administered 130 mg/m2 IV on Day 1 of each cycle, repeating every 21 days.
- Ziv-aflibercept: will be administered 6 mg/kg IV on Day 1 of each cycle, repeating every 21 days.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Arm A, Arm B
- Keywords
- Colorectal Cancer, Metastatic Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm ADrug
Also called Xeloda, ELOXATIN, ZALTRAP
- Capecitabine
- Oxaliplatin
- Ziv-aflibercept
Arm BDrug
Also called Xeloda, ELOXATIN, ZALTRAP
Capecitabine Oxaliplatin Ziv-aflibercept
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Arm A (every 2 week schedule) Dosage and dosage regimen for all study periods
* Capecitabine: will be administered 1,000 mg/m2 orally twice a day on Days 1 - 7 of each cycle, repeating every 14 days.
* Oxaliplatin: will be administered 85 mg/m2 IV on Day 1 of each cycle, repeating every 14 days.
* Ziv-aflibercept: will be administered 4 mg/kg IV on Day 1 of each cycle, repeating every 14 days. Receives: Drug: Arm A |
| Arm B | Experimental | Arm B (every 3 week schedule):
Dosage and dosage regimen for all study periods
* Capecitabine: will be administered 850 mg/m2 orally twice a day on Days 1 - 14 of each cycle, repeating every 21 days.
* Oxaliplatin: will be administered 130 mg/m2 IV on Day 1 of each cycle, repeating every 21 days.
* Ziv-aflibercept: will be administered 6 mg/kg IV on Day 1 of each cycle, repeating every 21 days. Receives: Drug: Arm B |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-tumor activity of ziv-aflibercept in combination with XELOX in the first-line treatment of patients with metastatic colorectal cancer (mCRC)
Measured: up to 6 years
Secondary outcomes (1)
Progression-free survival (PFS)
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: Funding for the study was withdrawn, no participants were ever recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor-investigator, James J Lee, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079220
- Sponsor's protocol ID
- 13-145
- Status last verified
- Jul 2017
- First submitted
- 3 Mar 2014
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Ziv-aflibercept in Combination With Capecitabine/Oxaliplatin (XELOX) Chemotherapy in the Front-Line Treatment of Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02079220
- Acronym / sponsor ID
- 13-145
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Colorectal Cancer, Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding for the study was withdrawn, no participants were ever recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- James J LeeUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Mar 2014
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, two-arm, phase II trial to evaluate the anti-tumor activity, safety, and tolerability of ziv-aflibercept in combination with XELOX chemotherapy in the first-line treatment of subjects with mCRC.
Two different schedules of ziv-aflibercept in combination with XELOX will be evaluated in this study: every 2 week schedule (Arm A) and the every 3 week schedule (Arm B). The choice between arm A and arm B will depend on the investigator's preference.
Arm A (every 2 week schedule) Dosage and dosage regimen for all study periods
- Capecitabine: will be administered 1,000 mg/m2 orally twice a day on Days 1 - 7 of each cycle, repeating every 14 days.
- Oxaliplatin: will be administered 85 mg/m2 IV on Day 1 of each cycle, repeating every 14 days.
- Ziv-aflibercept: will be administered 4 mg/kg IV on Day 1 of each cycle, repeating every 14 days.
Arm B (every 3 week schedule):
Dosage and dosage regimen for all study periods
- Capecitabine: will be administered 850 mg/m2 orally twice a day on Days 1 - 14 of each cycle, repeating every 21 days.
- Oxaliplatin: will be administered 130 mg/m2 IV on Day 1 of each cycle, repeating every 21 days.
- Ziv-aflibercept: will be administered 6 mg/kg IV on Day 1 of each cycle, repeating every 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Arm AArm A (every 2 week schedule) Dosage and dosage regimen for all study periods * Capecitabine: will be administered 1,000 mg/m2 orally twice a day on Days 1 - 7 of each cycle, repeating every 14 days. * Oxaliplatin: will be administered 85 mg/m2 IV on Day 1 of each cycle, repeating every 14 days. * Ziv-aflibercept: will be administered 4 mg/kg IV on Day 1 of each cycle, repeating every 14 days. |
| Arm B | Experimental | Drug: Arm BArm B (every 3 week schedule): Dosage and dosage regimen for all study periods * Capecitabine: will be administered 850 mg/m2 orally twice a day on Days 1 - 14 of each cycle, repeating every 21 days. * Oxaliplatin: will be administered 130 mg/m2 IV on Day 1 of each cycle, repeating every 21 days. * Ziv-aflibercept: will be administered 6 mg/kg IV on Day 1 of each cycle, repeating every 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- The study will be limited to subjects with newly diagnosed mCRC without any prior systemic chemotherapy for metastatic disease.
- The diagnosis of metastatic colorectal cancer will be based on histologic or cytologic confirmation.
- Subjects must have the ability to swallow oral medication.
- Subjects must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan, MRI, or calipers by clinical exam.
- Any prior chemotherapy for mCRC is not allowed. Adjuvant chemotherapy with oxaliplatin-containing regimen CRC within the last 12 months is not allowed. Adjuvant chemotherapy with Fluorouracil (5-FU) or capecitabine alone within the last 6 months is allowed.
Key exclusion criteria (27 listed)
- Unwilling or unable to follow protocol requirements or to give informed consent.
- Any prior chemotherapy for mCRC.
- Adjuvant chemotherapy with oxaliplatin-containing regimen CRC within the last 12 months.
- Adjuvant chemotherapy with 5-FU or capecitabine alone within the last 6 months is allowed.
- CrCl < 30 mL/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm AAlso: Xeloda, ELOXATIN, ZALTRAP* Capecitabine * Oxaliplatin * Ziv-aflibercept | Drug | Arm A |
| Arm BAlso: Xeloda, ELOXATIN, ZALTRAPCapecitabine Oxaliplatin Ziv-aflibercept | Drug | Arm B |
Primary outcome
anti-tumor activity of ziv-aflibercept in combination with XELOX in the first-line treatment of patients with metastatic colorectal cancer (mCRC)
Time frame: up to 6 years
1 secondary outcome
Progression-free survival (PFS)
Time frame: Up to 6 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arm A and Arm B in people with Metastatic Colorectal Cancer, run by James J Lee at 1 site 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 17 inclusion and 27 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 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
anti-tumor activity of ziv-aflibercept in combination with XELOX in the first-line treatment of patients with metastatic colorectal cancer (mCRC) (time frame: up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2017.