Metastatic Colorectal CancerPhase 1/2X-TRAPNCT01661972
Phase I/II Study of Capecitabine Plus Aflibercept to Treat Metastatic Colorectal Cancer
A Phase 1/2 study testing Capecitabine and aflibercept in people with Metastatic Colorectal Cancer, run by John Strickler, M.D. at 2 sites in United States.
Trial summary
The Primary Phase I objectives are to determine the recommended phase II dose for the capecitabine and aflibercept doublet combination; and to describe any dose limiting and non-dose limiting toxicities. The Phase II Primary objective is to determine progression free survival associated with this regimen. 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?
- Capecitabine and aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to 12 Jun 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- For the phase I portion, patients must have histologically and/or cytologically confirmed malignant solid tumor that is refractory to standard therapies.
- For the phase II portion, patients must have histologically and/or cytologically confirmed metastatic colorectal carcinoma that has progressed on, is intolerant of, or is inappropriate for all standard therapies. Subjects must have been treated with a fluoropyrimidine (e.g., 5-fluorouracil or capecitabine), oxaliplatin, irinotecan and bevacizumab or have contraindication to such treatment. Prior epithelial growth factor receptor (EGFR)-targeting agent (or contraindication to these drugs) is required for subjects with K-Ras wildtype tumors
- Measurable disease by RECIST 1.1 criteria (see Appendix 1). Previously irradiated sites can be included if there is documented progression of disease in that site.
- Age 18 years and older.
- KPS > 70% (see Appendix 2)
- Life expectancy > 3 months.
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- Adequate organ and marrow function as defined below:
- Absolute neutrophil count > 1.5 x 109/L
- Platelet count > 100 x 109/L
- Hemoglobin > 9 g/dl
- Total bilirubin < 1.5 x ULN
- AST (SGOT)/ALT (SGPT) < 2.5 x ULN (or <5 x ULN if liver metastases)
- Creatinine clearance ≥50 mls/min by Cockcroft-Gault
- Urine Protein/Creatinine ratio < 1 (or protein < 1+ on urinalysis or 24hour urine protein < 1gram/24 hours)
- Previous radiotherapy for palliation of recurrent disease is allowed if >4 weeks have elapsed since completion of therapy.
- Ability to take oral medications.
- Ability to understand and the willingness to sign a written informed consent document.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days from day 1 of study drug; both men and women must be willing to use two methods of contraception, one of them being a barrier method during the study and for 6 months after last study drug administration.
- Signed informed consent
Who cannot join
- Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks from day 1 of study drug (including investigational agents, chemotherapy, radiation therapy, antibody based therapy, etc.)
- History of severe hypersensitivity reactions/anaphylaxis attributed to humanized and/or chimeric monoclonal antibodies or other such proteins.
- History of significant intolerance to capecitabine or 5FU (ie. Grade 4 toxicity related to one of these agents; grade 3-4 toxicity related to other concurrently administered agents is not an exclusion).
- History of abdominal fistula or gastrointestinal perforation at any point within 6 months prior to day 1 of study drug, unless surgically repaired.
- Active peptic ulcer disease, inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), diverticular disease or other gastrointestinal conditions with increased risk of perforation or gastrointestinal bleeding.
- Active bleeding diathesis or history of any major bleeding, CNS bleeding, or significant hemoptysis within 6 months of enrollment.
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- Anticoagulation with warfarin (anticoagulation with low molecular weight heparin is not an exclusion).
- History of arterial thromboembolic events or symptomatic pulmonary embolism within 6 months of study enrollment.
- Poorly controlled hypertension [defined as systolic blood pressure (SBP of >150 mmHg or diastolic blood pressure (DBP) of >90 mmHg]
- Patients who have had a major surgery or significant traumatic injury within 4 weeks from day 1 of study drug.
- History of active brain metastases or carcinomatous meningitis (treated metastases are permitted, provided the patient is asymptomatic and off steroids for 28 days).
- Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. Two acceptable forms of contraceptives must be continued throughout the trial by either sex. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to day 1 of study drug).
- Any active infection, intercurrent illness, severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke Cancer Center, Duke University Medical Center
Durham, North Carolina, 27710
Virginia Oncology Associates
Norfolk, Virginia, 23502
About this study
Official title: X-TRAP: Phase I/II Study of Capecitabine Plus Aflibercept in Metastatic Colorectal Cancer
The Primary Phase I objectives are to determine the recommended phase II dose for the capecitabine and aflibercept doublet combination; and to describe any dose limiting and non-dose limiting toxicities. The Phase II Primary objective is to determine progression free survival associated with this regimen. The Phase II secondary objectives are to determine response rate associated with this regimen; to determine overall survival associated with this regimen; and to explore any correlation of clinical outcome with baseline and on treatment changes in blood-based angiogenesis biomarkers.
This open-label, non-randomized phase I/II trial is designed to assess the safety, tolerability and RPTD of capecitabine plus aflibercept in adult subjects with metastatic colorectal cancer.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Capecitabine and aflibercept
- Keywords
- colorectal cancer, all solid tumors, metastatic, refractory, advanced solid tumors
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine and afliberceptDrug
Capecitabine given on days 1-14 and off days 15-21. Dose: Phase 1 cohort 1 850mg/m2 Phase 1 cohort 2 1000mg/m2, Phase 2 RPTD.
Aflibercept will be held constant at 6 mg/kg, given intravenously every 3 weeks.
Both agents will be administered on a 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Capecitabine and Aflibercept | Experimental | A standard 3+3 dose escalation format will be used. Capecitabine will start at 850mg/m2 to be given on days 1-14 and off days 15-21. If tolerated, the dose will then be escalated to 1000mg/m2 for the next cohort, given on the same schedule. The dose of aflibercept will be held constant at 6 mg/kg, given intravenously every 3 weeks. Receives: Drug: Capecitabine and aflibercept |
| Phase 2: Capecitabine and Aflibercept | Experimental | Once the RPTD of the doublet combination has been identified, an additional 50 subjects with metastatic colorectal cancer will be added to a single, Phase 2 arm Receives: Drug: Capecitabine and aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase II Dose (RPTD) for the Capecitabine and Aflibercept Doublet Combination
Phase 1 of this study will be the dose escalation component to determine safety and the Recommended Phase II dose (RPTD) for the capecitabine plus aflibercept combination. Cohort 1 will receive 850mg/m2 capecitabine and 6mg/kg aflibercept. If less than 2 of 6 patients experience a dose limiting toxicity in Cohort 1, then the next patients will be enrolled in Cohort 2 at 1000mg/m2 capecitabine and 6mg/kg aflibercept. RPTD is determined by the number of dose limiting toxicities (Primary obj 2 for Phase I).
Measured: RPTD for the study will be determined at the completion of Phase I; up to 1 year.
Number of Dose-Limiting Toxicities (Phase 1)
Number of patients experiencing a dose-limiting toxicity in each cohort.
A dose-limiting toxicity is defined as Grade 4 neutropenia, thrombocytopenia or anemia or grade 3 neutropenia or thrombocytopenia lasting over 7 days Grade 3 thrombocytopenia associated with bleeding Febrile Neutropenia Nausea/Vomiting or Diarrhea ≥ grade 3 and lasting ≥ 4 days despite adequate supportive measures Grade ≥ 3 Bilirubin, ALT or AST > 7 days Other non-hematologic toxicity ≥ grade 3 excluding alopecia, anorexia, fatigue, hypertension, isolated lab abnormalities (not clinically significant) and/ rare, idiosyncratic reactions to any of the study drugs. Anorexia, fatigue and hypertension will be considered as DLT only if they reach grade 4 or are considered unmanageable Treatment delay of ≥ 14 days for cycle 2 due to unresolved toxicity Treatment-related death or clinically significant,treatment-related hospitalization
Measured: 28 days
Median Progression Free Survival (PFS)
Time in months from the start of study treatment to the date of first progression (PD) according to the RECIST criteria, or death due to any cause. Per RECIST criteria, a PD is indicated when there is at least a 20% increase in the sum of the longest diameters from target lesions relative to the smallest sum recorded since treatment is initiated. Median PFS was estimated using a Kaplan-Meier curve, and is the time at which 50% of patients remain alive without disease progression.
Measured: approximately 5 months
Secondary outcomes (2)
Response Rate
The percentage of patients for whom the best overall response is complete response (CR) or partial response (PR). A CR occurs when all lesions disappear; whereas, a PR is indicated when there is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesion. A PD (progressive disease) occurs when there is at least a 20% increase in the sum of the LD relative to the smallest sum LD recorded since treatment is initiated. Disease is considered stable if there is no response and no PD. All patients were assigned a best response for inclusion in this calculation in accordance with the protocol.
Measured: approximately every 9 weeks and/or restaging, through study completion
Median Survival
Time in months from the start of study treatment to date of death due to any cause. Median survival was estimated using a Kaplan-Meier curve and is the time point at which 50% of patients remain alive.
Measured: Subjects will be followed until death which is estimated to be on average 6 months - 1 year after coming off protocol therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startAug 2012
- Primary completion12 Jun 2016
- Study completion12 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Strickler, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor-investigator, John Strickler, M.D., Duke University
- Investigators
- John Strickler, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661972
- Sponsor's protocol ID
- Pro00037688
- Acronym
- X-TRAP
- Status last verified
- Oct 2018
- First submitted
- 31 Jul 2012
- Last updated
- 29 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Strickler JH, Rushing CN, Niedzwiecki D, McLeod A, Altomare I, Uronis HE, Hsu SD, Zafar SY, Morse MA, Chang DZ, Wells JL, Blackwell KL, Marcom PK, Arrowood C, Bolch E, Haley S, Rangwala FA, Hatch AJ, Nixon AB, Hurwitz HI. A phase Ib study of capecitabine and ziv-aflibercept followed by a phase II single-arm expansion cohort in chemotherapy refractory metastatic colorectal cancer. BMC Cancer. 2019 Nov 1;19(1):1032. doi: 10.1186/s12885-019-6234-8.
PubMed 31675952
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- X-TRAP: Phase I/II Study of Capecitabine Plus Aflibercept in Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01661972
- Acronym / sponsor ID
- X-TRAP / Pro00037688
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- colorectal cancer, all solid tumors, metastatic, refractory, advanced solid tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- John Strickler, M.D.University, hospital or other
- Collaborators
- Sanofi
- Study start
- Aug 2012
- Primary completion
- 12 Jun 2016 (actual)
- Study completion
- 12 Jun 2016 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Posted 11 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Primary Phase I objectives are to determine the recommended phase II dose for the capecitabine and aflibercept doublet combination; and to describe any dose limiting and non-dose limiting toxicities. The Phase II Primary objective is to determine progression free survival associated with this regimen. The Phase II secondary objectives are to determine response rate associated with this regimen; to determine overall survival associated with this regimen; and to explore any correlation of clinical outcome with baseline and on treatment changes in blood-based angiogenesis biomarkers.
This open-label, non-randomized phase I/II trial is designed to assess the safety, tolerability and RPTD of capecitabine plus aflibercept in adult subjects with metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Capecitabine and Aflibercept | Experimental | Drug: Capecitabine and afliberceptA standard 3+3 dose escalation format will be used. Capecitabine will start at 850mg/m2 to be given on days 1-14 and off days 15-21. If tolerated, the dose will then be escalated to 1000mg/m2 for the next cohort, given on the same schedule. The dose of aflibercept will be held constant at 6 mg/kg, given intravenously every 3 weeks. |
| Phase 2: Capecitabine and Aflibercept | Experimental | Drug: Capecitabine and afliberceptOnce the RPTD of the doublet combination has been identified, an additional 50 subjects with metastatic colorectal cancer will be added to a single, Phase 2 arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- For the phase I portion, patients must have histologically and/or cytologically confirmed malignant solid tumor that is refractory to standard therapies.
- For the phase II portion, patients must have histologically and/or cytologically confirmed metastatic colorectal carcinoma that has progressed on, is intolerant of, or is inappropriate for all standard therapies. Subjects must have been treated with a fluoropyrimidine (e.g., 5-fluorouracil or capecitabine), oxaliplatin, irinotecan and bevacizumab or have contraindication to such treatment. Prior epithelial growth factor receptor (EGFR)-targeting agent (or contraindication to these drugs) is required for subjects with K-Ras wildtype tumors
- Measurable disease by RECIST 1.1 criteria (see Appendix 1). Previously irradiated sites can be included if there is documented progression of disease in that site.
- Age 18 years and older.
- KPS > 70% (see Appendix 2)
Key exclusion criteria (13 listed)
- Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks from day 1 of study drug (including investigational agents, chemotherapy, radiation therapy, antibody based therapy, etc.)
- History of severe hypersensitivity reactions/anaphylaxis attributed to humanized and/or chimeric monoclonal antibodies or other such proteins.
- History of significant intolerance to capecitabine or 5FU (ie. Grade 4 toxicity related to one of these agents; grade 3-4 toxicity related to other concurrently administered agents is not an exclusion).
- History of abdominal fistula or gastrointestinal perforation at any point within 6 months prior to day 1 of study drug, unless surgically repaired.
- Active peptic ulcer disease, inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), diverticular disease or other gastrointestinal conditions with increased risk of perforation or gastrointestinal bleeding.
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 |
|---|---|---|
| Capecitabine and afliberceptCapecitabine given on days 1-14 and off days 15-21. Dose: Phase 1 cohort 1 850mg/m2 Phase 1 cohort 2 1000mg/m2, Phase 2 RPTD. Aflibercept will be held constant at 6 mg/kg, given intravenously every 3 weeks. Both agents will be administered on a 21-day cycle. | Drug | Phase 1: Capecitabine and Aflibercept, Phase 2: Capecitabine and Aflibercept |
Primary outcome
Recommended Phase II Dose (RPTD) for the Capecitabine and Aflibercept Doublet Combination
Time frame: RPTD for the study will be determined at the completion of Phase I; up to 1 year.
Phase 1 of this study will be the dose escalation component to determine safety and the Recommended Phase II dose (RPTD) for the capecitabine plus aflibercept combination. Cohort 1 will receive 850mg/m2 capecitabine and 6mg/kg aflibercept. If less than 2 of 6 patients experience a dose limiting toxicity in Cohort 1, then the next patients will be enrolled in Cohort 2 at 1000mg/m2 capecitabine and 6mg/kg aflibercept. RPTD is determined by the number of dose limiting toxicities (Primary obj 2 for Phase I).
Number of Dose-Limiting Toxicities (Phase 1)
Time frame: 28 days
Number of patients experiencing a dose-limiting toxicity in each cohort. A dose-limiting toxicity is defined as Grade 4 neutropenia, thrombocytopenia or anemia or grade 3 neutropenia or thrombocytopenia lasting over 7 days Grade 3 thrombocytopenia associated with bleeding Febrile Neutropenia Nausea/Vomiting or Diarrhea ≥ grade 3 and lasting ≥ 4 days despite adequate supportive measures Grade ≥ 3 Bilirubin, ALT or AST > 7 days Other non-hematologic toxicity ≥ grade 3 excluding alopecia, anorexia, fatigue, hypertension, isolated lab abnormalities (not clinically significant) and/ rare, idiosyncratic reactions to any of the study drugs. Anorexia, fatigue and hypertension will be considered as DLT only if they reach grade 4 or are considered unmanageable Treatment delay of ≥ 14 days for cycle 2 due to unresolved toxicity Treatment-related death or clinically significant,treatment-related hospitalization
Median Progression Free Survival (PFS)
Time frame: approximately 5 months
Time in months from the start of study treatment to the date of first progression (PD) according to the RECIST criteria, or death due to any cause. Per RECIST criteria, a PD is indicated when there is at least a 20% increase in the sum of the longest diameters from target lesions relative to the smallest sum recorded since treatment is initiated. Median PFS was estimated using a Kaplan-Meier curve, and is the time at which 50% of patients remain alive without disease progression.
2 secondary outcomes
Response Rate
Time frame: approximately every 9 weeks and/or restaging, through study completion
Median Survival
Time frame: Subjects will be followed until death which is estimated to be on average 6 months - 1 year after coming off protocol therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31675952Strickler JH, Rushing CN, Niedzwiecki D, McLeod A, Altomare I, Uronis HE, Hsu SD, Zafar SY, Morse MA, Chang DZ, Wells JL, Blackwell KL, Marcom PK, Arrowood C, Bolch E, Haley S, Rangwala FA, Hatch AJ, Nixon AB, Hurwitz HI. A phase Ib study of capecitabine and ziv-aflibercept followed by a phase II single-arm expansion cohort in chemotherapy refractory metastatic colorectal cancer. BMC Cancer. 2019 Nov 1;19(1):1032. doi: 10.1186/s12885-019-6234-8.
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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.
John Strickler, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Capecitabine and aflibercept in people with Metastatic Colorectal Cancer, run by John Strickler, M.D. at 2 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 19 inclusion and 13 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: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 11 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recommended Phase II Dose (RPTD) for the Capecitabine and Aflibercept Doublet Combination (time frame: RPTD for the study will be determined at the completion of Phase I; up to 1 year.). The study lists 3 primary outcomes in all. 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 NCT01661972, which also lists 1 linked publication.
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 29 Oct 2018.