Anal, Colon, and Rectal CancersPhase 1NCT00532909
Phase I Vandetanib Plus Capecitabine, Oxaliplatin and Bevacizumab for Metastatic Colorectal Cancer
A Phase 1 study testing Vandetanib, Capecitabine and Oxaliplatin in people with Anal, Colon, and Rectal Cancers and Colorectal Neoplasms, run by Branimir Sikic at 1 site in United States.
Trial summary
To determine the maximum tolerated dose of Vandetanib with a current standard first-line chemotherapy regimen, capecitabine and oxaliplatin without and then with bevacizumab for the first line treatment of metastatic colorectal cancer (CRC) and to define the dose limiting toxicities associated with the combination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal, Colon, and Rectal Cancers, Colorectal Neoplasms, Colon/Rectal Cancer
- What is being tested?
- Vandetanib, Capecitabine and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to May 2010
- Phase
- Phase 1
- 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
- Provision of signed informed consent.
- Female and or male age 18 years and over.
- Negative pregnancy test for women of childbearing potential.
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
- Patients with a history of colorectal adenocarcinoma treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease. Clinicians should consider biopsy of lesions to establish diagnosis of metastatic colorectal adenocarcinoma if there is substantial clinical ambiguity regarding the nature or source of apparent metastases.
- A primary or metastatic lesion measurable in at least one dimension by RECIST criteria within 4 weeks prior to entry of study
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- WHO performance status of 0-2
- Laboratory values<= 2 weeks prior to randomization:
- Absolute Neutrophil Count (ANC) >=1.5 x 10^9/L (>=1500/mm^3) Platelets (PLT) >=100 x 10^9/L (>=100,000/mm^3) Hemoglobin (Hgb) >=9 g/dL Serum creatinine <=1.5 x ULN Serum bilirubin <=1.5 x ULN Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) <=2.5 x ULN (<=5 x ULN if liver metastases present). Note: ERCP or percutaneous stenting may be used to normalize the liver function tests.
- Negative or trace for proteinuria based on dip stick reading OR, if documentation of +1 result for protein on dip stick reading, then total urinary protein <=500 mg and measured creatinine clearance (CrCl) >=50 mL/min from a 24-hour urine collection
- Life expectancy >12 weeks
Who cannot join
- Laboratory results:
- Serum bilirubin >1.5 x the upper limit of reference range (ULRR) Serum creatinine >1.5 x ULRR or creatinine clearance >= 50 mL/minute (calculated by Cockcroft-Gault formula.) Potassium <4.0 mmol/L despite supplementation; serum calcium (ionized or adjusted for albumin,) or magnesium out of normal range despite supplementation.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x ULRR or alkaline phosphatase (ALP) >2.5 x ULRR, or >5x ULRR if judged by the investigator to be related to liver metastases
- Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
- Clinically significant cardiac event such as myocardial infarction; New York Heart Association (NYHA) classification of heart disease >= 2 within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
- History of arrhythmia (multifocal premature ventricular contractions (PVCs), bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication, is not excluded.
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- Previous history of QTc prolongation as a result from other medication that required discontinuation of that medication.
- Congenital long QT syndrome, or 1st degree relative with unexplained sudden death under 40 years of age.
- Presence of left bundle branch block (LBBB.)
- QTc with Bazett's correction that is unmeasurable, or <480 msec on screening ECG. If a patient has QTc >= 480 msec on screening ECG, the screen ECG may be repeated twice (at least 24 hours apart). The average QTc from the three screening ECGs must be <480 msec in order for the patient to be eligible for the study.)
- Any concomitant medication that may cause QTc prolongation, induce Torsades de Pointes or induce CYP3A4 function
- Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg)
- Currently active diarrhea that may affect the ability of the patient to absorb the vandetanib or tolerate diarrhea.
- Women who are currently pregnant or breastfeeding.
- Previous or current malignancies of other histologies within the last 5 years, with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
- Receipt of any investigational agents within 30 days prior to commencing study treatment
- Last dose of prior chemotherapy discontinued less than 4 weeks before the start of study therapy
- Last radiation therapy within the last 4 weeks before the start of study therapy, except palliative radiotherapy
- Any unresolved toxicity greater than CTC grade 1 from previous anti-cancer therapy
- Previous enrollment or randomization of treatment in the present study
- Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase I Trial of Vandetanib Combined With Capecitabine, Oxaliplatin and Bevacizumab for the First-Line Treatment of Metastatic Colorectal Cancer
To determine the maximum tolerated dose of Vandetanib with a current standard first-line chemotherapy regimen, capecitabine and oxaliplatin without and then with bevacizumab for the first line treatment of metastatic colorectal cancer (CRC) and to define the dose limiting toxicities associated with the combination.
- Being tested
- Vandetanib, Capecitabine, Oxaliplatin, Bevacizumab
- Medical subject headings
- Rectal Neoplasms, Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VandetanibDrug
100mg or 300mg By mouth every day continuous
CapecitabineDrug
Dosage: 1000mg/m2 By mouth twice a day for 14 days or reduced dose of 800mg/m2 PO BID days1-14.
OxaliplatinDrug
dosage: 130mg/m2. IV Day 1 of a 21 day cycle or reduced dose of 100mg/m2 IV Day 1.
BevacizumabDrug
Dosage: 7.5mg/kg or 10mg/kg. IV Day 1 (21 day cycle)
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of vandetanib in combination with capecitabine, oxaliplatin and bevacizumab
Measured: Following treatment
Secondary outcomes (3)
Effect of vandetanib on the pharmacokinetics (PK) of capecitabine and oxaliplatin
Measured: During and following treatment
Effects of this treatment on tumor remission, progression free survival, and overall survival of patients
Measured: Following treatment
Dose limiting toxicities associated with the combination
Measured: During and following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startJul 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal, Colon, and Rectal CancersStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Branimir Sikic
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Branimir Sikic, Stanford University
- Investigators
- Branimir I Sikic, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532909
- Sponsor's protocol ID
- COR0006
- Other IDs
- 97132, COR0006, NCT00532909
- Status last verified
- Jul 2012
- First submitted
- 20 Sep 2007
- Last updated
- 16 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Vandetanib Combined With Capecitabine, Oxaliplatin and Bevacizumab for the First-Line Treatment of Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00532909
- Acronym / sponsor ID
- COR0006
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Branimir SikicUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jul 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 21 Sep 2007 (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.
To determine the maximum tolerated dose of Vandetanib with a current standard first-line chemotherapy regimen, capecitabine and oxaliplatin without and then with bevacizumab for the first line treatment of metastatic colorectal cancer (CRC) and to define the dose limiting toxicities associated with the combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of signed informed consent.
- Female and or male age 18 years and over.
- Negative pregnancy test for women of childbearing potential.
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
- Patients with a history of colorectal adenocarcinoma treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease. Clinicians should consider biopsy of lesions to establish diagnosis of metastatic colorectal adenocarcinoma if there is substantial clinical ambiguity regarding the nature or source of apparent metastases.
Key exclusion criteria (21 listed)
- Laboratory results:
- Serum bilirubin >1.5 x the upper limit of reference range (ULRR) Serum creatinine >1.5 x ULRR or creatinine clearance >= 50 mL/minute (calculated by Cockcroft-Gault formula.) Potassium <4.0 mmol/L despite supplementation; serum calcium (ionized or adjusted for albumin,) or magnesium out of normal range despite supplementation.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x ULRR or alkaline phosphatase (ALP) >2.5 x ULRR, or >5x ULRR if judged by the investigator to be related to liver metastases
- Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
- Clinically significant cardiac event such as myocardial infarction; New York Heart Association (NYHA) classification of heart disease >= 2 within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
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 |
|---|---|---|
| Vandetanib100mg or 300mg By mouth every day continuous | Drug | – |
| CapecitabineDosage: 1000mg/m2 By mouth twice a day for 14 days or reduced dose of 800mg/m2 PO BID days1-14. | Drug | – |
| Oxaliplatindosage: 130mg/m2. IV Day 1 of a 21 day cycle or reduced dose of 100mg/m2 IV Day 1. | Drug | – |
| BevacizumabDosage: 7.5mg/kg or 10mg/kg. IV Day 1 (21 day cycle) | Drug | – |
Primary outcome
Maximum tolerated dose of vandetanib in combination with capecitabine, oxaliplatin and bevacizumab
Time frame: Following treatment
3 secondary outcomes
Effect of vandetanib on the pharmacokinetics (PK) of capecitabine and oxaliplatin
Time frame: During and following treatment
Effects of this treatment on tumor remission, progression free survival, and overall survival of patients
Time frame: Following treatment
Dose limiting toxicities associated with the combination
Time frame: During and following treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
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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.
Branimir I Sikic principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vandetanib, Capecitabine and Oxaliplatin in people with Anal, Colon, and Rectal Cancers and Colorectal Neoplasms, run by Branimir Sikic 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 11 inclusion and 21 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 16 Jul 2012. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum tolerated dose of vandetanib in combination with capecitabine, oxaliplatin and bevacizumab (time frame: Following treatment). 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 16 Jul 2012.