Unspecified Adult Solid Tumor, Protocol SpecificPhase 1COBRANCT00849550
Safety and Dosage Study of RAD001 (Everolimus) in Combination With Current Standard of Care to Treat Advanced Solid Tumors.
A Phase 1 study testing capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev) in people with Unspecified Adult Solid Tumor, Protocol Specific and Cancer, run by Herbert Hurwitz at 3 sites in United States.
Trial summary
The purpose of this study is to determine if RAD001 (everolimus) helps improve the standard treatment of XELOX-A (bevacizumab, oxaliplatin, capecitabine) in advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific, Cancer
- What is being tested?
- capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2009to Dec 2012
- 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
- Must be 18 years or older
- Must have a performance status of at least 70% (able to carry on most normal activities)
- Must have life expectancy of at least 3 months
- Must have adequate organ and marrow function as determined by lab tests
- Women of child-bearing potential and men must agree to use two forms of contraception
- Ability and willingness to sign a written informed consent document
- Histologically confirmed solid tumor malignancy that is metastatic or unresectable
Who cannot join
- Pregnant or breastfeeding and/or lactating women
- Patients who have received any other investigational agents within 28 days of the first day of study drug
- Patients with known CNS metastases
- History of other carcinomas within last 5 years (except non-melanoma skin cancer, in-situ cervical cancer, localized prostate cancer)
- Inadequately controlled hypertension
- Significant vascular disease
Show all 16Show fewer
- Invasion or encasement of a major artery
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 of study drug
- Serious illness or medical condition
- History of myocardial infarction, unstable angina, cardiac or other vascular stenting
- History of stroke
- HIV, Hepatitis C, Hepatitis B or other serious chronic infection
- Impairment of Gastrointestinal function or disease
- History of interstitial lung disease
- Patients who have had radiation therapy, hormonal therapy, biologic therapy or chemotherapy for cancer within 28 days of receiving study drug.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke University Medical Center
Durham, North Carolina, 27710
Ingalls Cancer Research Center
Harvey, Illinois, 60426
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
About this study
Official title: A Phase I Study of Capecitabine, Oxaliplatin, Bevacizumab, and RAD001 (XELOX-A-Ev) for Subjects With Advanced Solid Tumors
The purpose of this study is to determine if RAD001 (everolimus) helps improve the standard treatment of XELOX-A (bevacizumab, oxaliplatin, capecitabine) in advanced solid tumors.
- Being tested
- capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)
- Keywords
- Advanced Solid Tumors, Cancer, Capecitabine, XELOX, Neoplasms, Oxaliplatin, Bevacizumab, RAD001
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)Drug
bevacizumab IV, capecitabine oral, oxaliplatin IV, RAD001 oral
| Study group | Role | What they receive |
|---|---|---|
| XELOX-A-Ev | Experimental | Not described Receives: Drug: capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the MTD/RPTD of capecitabine/oxaliplatin/bevacizumab/everolimus (XELOX-A-Ev) for subjects with advanced solid tumors.
Measured: End of treatment phase
Secondary outcomes (2)
Describe dose-limiting and non-dose-limiting toxicities
Measured: End of treatment phase
preliminarily investigate the response rate and PFS
Measured: from response to progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herbert Hurwitz
- Sponsor type
- University, hospital or other
- Collaborators
- Roche-Genentech, Novartis
- Responsible party
- Sponsor-investigator, Herbert Hurwitz, Duke University
- Investigators
- Herbert Hurwitz, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849550
- Sponsor's protocol ID
- Pro00015605
- Other IDs
- 4265
- Acronym
- COBRA
- Status last verified
- Dec 2012
- First submitted
- 22 Feb 2009
- Last updated
- 24 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Capecitabine, Oxaliplatin, Bevacizumab, and RAD001 (XELOX-A-Ev) for Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00849550
- Acronym / sponsor ID
- COBRA / Pro00015605
- Keywords
- Advanced Solid Tumors, Cancer, Capecitabine, XELOX, Neoplasms, Oxaliplatin, Bevacizumab, RAD001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Herbert HurwitzUniversity, hospital or other
- Collaborators
- Roche-Genentech, Novartis
- Study start
- Jul 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Feb 2009 (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.
The purpose of this study is to determine if RAD001 (everolimus) helps improve the standard treatment of XELOX-A (bevacizumab, oxaliplatin, capecitabine) in advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XELOX-A-Ev | Experimental | Drug: capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must be 18 years or older
- Must have a performance status of at least 70% (able to carry on most normal activities)
- Must have life expectancy of at least 3 months
- Must have adequate organ and marrow function as determined by lab tests
- Women of child-bearing potential and men must agree to use two forms of contraception
Key exclusion criteria (16 listed)
- Pregnant or breastfeeding and/or lactating women
- Patients who have received any other investigational agents within 28 days of the first day of study drug
- Patients with known CNS metastases
- History of other carcinomas within last 5 years (except non-melanoma skin cancer, in-situ cervical cancer, localized prostate cancer)
- Inadequately controlled hypertension
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/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)bevacizumab IV, capecitabine oral, oxaliplatin IV, RAD001 oral | Drug | XELOX-A-Ev |
Primary outcome
To determine the MTD/RPTD of capecitabine/oxaliplatin/bevacizumab/everolimus (XELOX-A-Ev) for subjects with advanced solid tumors.
Time frame: End of treatment phase
2 secondary outcomes
Describe dose-limiting and non-dose-limiting toxicities
Time frame: End of treatment phase
preliminarily investigate the response rate and PFS
Time frame: from response to progression
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 24 Dec 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.
Herbert Hurwitz, MD principal investigator
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev) in people with Unspecified Adult Solid Tumor, Protocol Specific and Cancer, run by Herbert Hurwitz 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 7 inclusion and 16 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 24 Dec 2012. 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.
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?
To determine the MTD/RPTD of capecitabine/oxaliplatin/bevacizumab/everolimus (XELOX-A-Ev) for subjects with advanced solid tumors. (time frame: End of treatment phase). 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 24 Dec 2012.