Colon CancerPhase 2NCT00766220
Yttrium Microspheres With Cetuximab Plus Irinotecan for Patients With Advanced Colorectal Cancer Mets to Liver
A Phase 2 study testing SIR-spheres Agent Administration, Cetuximab and Irinotecan in people with Colon Cancer and Colorectal Cancer, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to find out what effects radioactive particles, SIR-spheres, have when injected into the liver, followed by systemic chemotherapy with a combination of cetuximab and irinotecan compared to those who have systemic therapy alone, in patients with colon cancer that has… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Colorectal Cancer
- What is being tested?
- SIR-spheres Agent Administration, Cetuximab and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Jan 2012
- 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
- Patients must have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Histology from the hepatic metastasis is not mandatory if the morphological appearances on cross sectional imaging and tumor markers (CEA) are indicative of a colorectal primary.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in two dimensions (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT scan.
- Patients must have radiological evidence of disease progression of disease within 6 months of their most recent dose of chemotherapeutic regimens .
- Age greater than or equal to 18 years.
- ECOG performance status less than or equal to 2.
- Patients must have normal organ and marrow function as defined below within 30 days of receiving the investigational agent: - leukocytes greater than or equal to 3,000/mL - absolute neutrophil count greater than or equal to 1,500/mL - platelets greater than or equal to 100,000/mL - total bilirubin less than or equal to 1.5 times upper limits of normal institutional limits - AST(SGOT) less than or equal to 3 X ULN and ALT(SGPT) less than or equal to 3 X ULN - Creatinine less than or equal to 1.5 times upper limits of normal institutional limits
Show all 12Show fewer
- Patients with a prior history of non-colorectal cancer who have no active disease may be eligible if they are disease free for greater than or equal to 12 months prior to treatment.
- The effects of SIR-Spheres, irinotecan or cetuximab on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because radiation as well as other therapeutic agents used in this trial are known to be teratogenic, 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. Should a woman become pregnant or suspect she is pregnant while in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients without evidence of local disease recurrence from colorectal cancer are eligible
- Patients with extrahepatic disease confined to the lung is permitted if < 4 lesions are depicted on CTand all are < 3 cm in size
- Patients with brain mets are eligible for this trial if those patients who have had the area surgically resected or irradiated and have no evidence of active disease as demonstrated by MRI of the brain. Patients must have no evidence of residual neurological dysfunction as per baseline neurological exam. Patients with untreated brain metastases will be considered ineligible.
Who cannot join
- Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier will be excluded. Patients who have had hepatic external beam radiotherapy will be excluded.
- Patients may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to SIR-Spheres, irinotecan or cetuximab or other agents used in the study.
- Evidence of ascites, biopsy proven cirrhosis or portal hypertension suggested by the presence of characteristic imaging features on cross sectional imaging or esophageal varicosities demonstrated on endoscopy or barium swallow. A diagnostic study to rule out the presence of portal hypertension will not be required unless the findings on cross sectional imaging are suggestive but not confirmatory.
- Hepatic arterial anatomy that would prevent catheterization and the administration of SIR-Spheres into the liver.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring hospital admission or antibiotics,symptomatic congestive heart failure (class III and IV), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations would exclude patients from this study.
Show all 9Show fewer
- Contraindications to angiography and selective visceral catheterization: History of severe allergy or intolerance to any contrast media, or atropine. Bleeding diathesis, not correctable by usual forms of therapy that would include medical coagulopathy but not limited to the administration of blood products.
- Utilization of capecitabine for the 6 weeks preceding SIR-Sphere therapy and indefinitely following SIR-Sphere therapy as per manufacturer's recommendations due to the increased risk of radiation hepatitis.
- Patients exhibiting the mutant variety for kras will be excluded for participation in the study.
About this study
Official title: Phase II Randomized Study of SIR-Spheres, Yttrium Microspheres With Cetuximab Plus Irinotecan for Patients With Advanced Colorectal Cancer Metastases to the Liver
The goal of this clinical research study is to find out what effects radioactive particles, SIR-spheres, have when injected into the liver, followed by systemic chemotherapy with a combination of cetuximab and irinotecan compared to those who have systemic therapy alone, in patients with colon cancer that has metastasized to the liver. The safety of this treatment and how well it controls the disease will also be studied.
Read the detailed description
Yttrium microspheres are designed to treat cancer that has metastasized to the liver by giving radiation directly to the tumor. SIR-spheres are designed to deliver radiation directly to the tumor. This radiation kills the tumor cells.
Cetuximab is a drug that blocks epidermal growth factor receptor (EGFR). EGFR may be involved in certain types of cancer, including non small-cell lung cancer (NSCLC). When EGFR is stimulated, a series of chemical reactions start that result in a tumor being "told" to grow. Cetuximab tries to stop these reactions by blocking EGFR. This may stop tumors from growing.
Irinotecan is designed to block cell growth by blocking an enzyme that repairs DNA, the building blocks of cells.
If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1of 2 groups. Participants in one group will receive the SIR-spheres with Cetuximab and Irinotecan therapy. Participants in the other group will just have the Cetuximab and Irinotecan therapy without the SIR-spheres. There is an equal chance of being assigned to either group.
If you are found to be eligible to take part in this study, you will have a blood vessel study (given with x-ray dye) performed. This will help researchers look at the arteries leading to your liver and the surrounding areas. You will receive Versed and Fentanyl, sedative drugs to put you to sleep, intravenously (IV--through a needle in a vein) in your arm. A catheter will be placed through your groin artery into the artery leading to your liver. A catheter is a sterile flexible tube that will be placed into a large artery while you are under local anesthesia and IV sedation. Your physician will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure. X-ray dye will be injected through the catheter.
If randomly selected to receive the SIR-Spheres with Cetuximab and Irinotecan therapy, a small amount of radioactive albumin injection (a part of a scan test used to measure the supply of blood through the lungs) will be given to your liver. Images will then be taken to learn if too much of this material (radioactive particles) shows up in your lungs and if your liver anatomy is normal. If everything appears normal, the yttrium microspheres will be given slowly through the catheter in 1 dose. If your liver anatomy is abnormal, the yttrium microspheres will be given slowly through the catheter in 2 doses. After you are given the yttrium microspheres, the catheter will be removed, and pressure will be applied to your groin to stop any bleeding. You will then be monitored for 6 hours to check on your well being. You will be given pain medication, if needed (the same sedative drugs used before).
You will be given standard doses of Zantac (ranitidine) to help to protect the stomach during treatment. Chemotherapy with cetuximab and irinotecan will be given on an outpatient basis. A catheter (PICC line, port-a-cath) may be inserted through a vein in your arm or chest to ensure that the chemotherapy is given without interruption. Irinotecan will be given by IV over 90 minutes, once every 3 weeks. Cetuximab will be given once a week. On Day 1 of treatment, you will be given a test dose of cetuximab, to check for any allergic reactions. After that, cetuximab will be given by IV over 2 hours. Before every dose of cetuximab, you will be given a dose of diphenhydramine by IV, to keep from having any allergic reactions. You will also receive medication to prevent nausea, vomiting, or an allergic reaction.
You will have a single-photon emission computerized tomography (SPECT) scan within 1 week after your treatment. A SPECT scan lets your doctor study the function of your internal organs. You will have blood (about 2 tablespoons) drawn every week for the first 2 months and then once a month on an outpatient basis. This is so researchers can check the function of your kidneys and liver. You will also have a routine physical exam and a computerized tomography (CT) scan performed once a month to check the growth of your tumor. Researchers will check to see if your tumor is responding to the study treatment by looking at the imaging on CT scans every 8 weeks.
You may be taken off this study if your disease gets worse, if you experience intolerable side effects, or if there is not enough of the study drug supply to continue treating your disease.
You will be followed-up by telephone for as long as you have cancer.
This is an investigational study. Yttrium microspheres are FDA approved for hepatic arterial therapy and treatment of liver metastases. Sir-Sphere therapy has been approved for treating colorectal cancer with liver metastases. The combination of cetuximab and irinotecan is FDA approved for metastatic colorectal cancer. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Colon Cancer, Colorectal Cancer
- Being tested
- SIR-spheres Agent Administration, Cetuximab, Irinotecan
- Keywords
- Colon, Liver, Colorectal cancer, Colorectal cancer metastases to the liver, Metastases to the liver, Colorectal cancer mets to liver, Colon cancer metastasized to liver, Yttrium microspheres, SIR-Spheres, Yttrium-90, Cetuximab, C225, Erbitux, IMC-C225, Irinotecan, CPT-11, Liver directed therapy
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIR-spheres Agent AdministrationDrug
Also called Yttrium-90, Yttrium 90, Yttrium microspheres
SIR-Spheres, resin microspheres containing pure Beta emitter Yttrium-90, given through femoral catheter over 10 minutes.
CetuximabDrug
Also called C225, Erbitux™, IMC-C225
400 mg/m2 by vein over 2 hours once a week.
Cetuximab infusions will be continued weekly at a dose of 250 mg/m2 unless toxicity necessitates interruptions.
IrinotecanDrug
Also called CPT-11
350 mg/m2 (or 300 mg/m2 in patients who are greater or equal to 70 years of age, or have an ECOG PS of 2 or have had prior pelvic and/or abdominal irradiation), by vein over 90 minutes, every three weeks.
| Study group | Role | What they receive |
|---|---|---|
| SIR-Spheres + Therapy | Active comparator | SIR-Spheres with Cetuximab + Irinotecan Therapy Receives: Drug: SIR-spheres Agent Administration; Drug: Cetuximab; Drug: Irinotecan |
| Therapy Only | Active comparator | Cetuximab + Irinotecan Therapy Receives: Drug: Cetuximab; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startOct 2009
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Slow Accrual and withdrawn/exclusion of 2 participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sirtex Medical
- Responsible party
- Sponsor
- Investigators
- Ravi Murthy, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766220
- Sponsor's protocol ID
- 2004-0779
- Status last verified
- Dec 2012
- First submitted
- 1 Oct 2008
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study of SIR-Spheres, Yttrium Microspheres With Cetuximab Plus Irinotecan for Patients With Advanced Colorectal Cancer Metastases to the Liver
- ClinicalTrials.gov ID
- NCT00766220
- Acronym / sponsor ID
- 2004-0779
- Conditions
- Colon Cancer, Colorectal Cancer
- Keywords
- Colon, Liver, Colorectal cancer, Colorectal cancer metastases to the liver, Metastases to the liver, Colorectal cancer mets to liver, Colon cancer metastasized to liver, Yttrium microspheres
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow Accrual and withdrawn/exclusion of 2 participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Sirtex Medical
- Study start
- Oct 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 3 Oct 2008 (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 goal of this clinical research study is to find out what effects radioactive particles, SIR-spheres, have when injected into the liver, followed by systemic chemotherapy with a combination of cetuximab and irinotecan compared to those who have systemic therapy alone, in patients with colon cancer that has metastasized to the liver. The safety of this treatment and how well it controls the disease will also be studied.
Detailed description
Yttrium microspheres are designed to treat cancer that has metastasized to the liver by giving radiation directly to the tumor. SIR-spheres are designed to deliver radiation directly to the tumor. This radiation kills the tumor cells.
Cetuximab is a drug that blocks epidermal growth factor receptor (EGFR). EGFR may be involved in certain types of cancer, including non small-cell lung cancer (NSCLC). When EGFR is stimulated, a series of chemical reactions start that result in a tumor being "told" to grow. Cetuximab tries to stop these reactions by blocking EGFR. This may stop tumors from growing.
Irinotecan is designed to block cell growth by blocking an enzyme that repairs DNA, the building blocks of cells.
If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1of 2 groups. Participants in one group will receive the SIR-spheres with Cetuximab and Irinotecan therapy. Participants in the other group will just have the Cetuximab and Irinotecan therapy without the SIR-spheres. There is an equal chance of being assigned to either group.
If you are found to be eligible to take part in this study, you will have a blood vessel study (given with x-ray dye) performed. This will help researchers look at the arteries leading to your liver and the surrounding areas. You will receive Versed and Fentanyl, sedative drugs to put you to sleep, intravenously (IV--through a needle in a vein) in your arm. A catheter will be placed through your groin artery into the artery leading to your liver. A catheter is a sterile flexible tube that will be placed into a large artery while you are under local anesthesia and IV sedation. Your physician will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure. X-ray dye will be injected through the catheter.
If randomly selected to receive the SIR-Spheres with Cetuximab and Irinotecan therapy, a small amount of radioactive albumin injection (a part of a scan test used to measure the supply of blood through the lungs) will be given to your liver. Images will then be taken to learn if too much of this material (radioactive particles) shows up in your lungs and if your liver anatomy is normal. If everything appears normal, the yttrium microspheres will be given slowly through the catheter in 1 dose. If your liver anatomy is abnormal, the yttrium microspheres will be given slowly through the catheter in 2 doses. After you are given the yttrium microspheres, the catheter will be removed, and pressure will be applied to your groin to stop any bleeding. You will then be monitored for 6 hours to check on your well being. You will be given pain medication, if needed (the same sedative drugs used before).
You will be given standard doses of Zantac (ranitidine) to help to protect the stomach during treatment. Chemotherapy with cetuximab and irinotecan will be given on an outpatient basis. A catheter (PICC line, port-a-cath) may be inserted through a vein in your arm or chest to ensure that the chemotherapy is given without interruption. Irinotecan will be given by IV over 90 minutes, once every 3 weeks. Cetuximab will be given once a week. On Day 1 of treatment, you will be given a test dose of cetuximab, to check for any allergic reactions. After that, cetuximab will be given by IV over 2 hours. Before every dose of cetuximab, you will be given a dose of diphenhydramine by IV, to keep from having any allergic reactions. You will also receive medication to prevent nausea, vomiting, or an allergic reaction.
You will have a single-photon emission computerized tomography (SPECT) scan within 1 week after your treatment. A SPECT scan lets your doctor study the function of your internal organs. You will have blood (about 2 tablespoons) drawn every week for the first 2 months and then once a month on an outpatient basis. This is so researchers can check the function of your kidneys and liver. You will also have a routine physical exam and a computerized tomography (CT) scan performed once a month to check the growth of your tumor. Researchers will check to see if your tumor is responding to the study treatment by looking at the imaging on CT scans every 8 weeks.
You may be taken off this study if your disease gets worse, if you experience intolerable side effects, or if there is not enough of the study drug supply to continue treating your disease.
You will be followed-up by telephone for as long as you have cancer.
This is an investigational study. Yttrium microspheres are FDA approved for hepatic arterial therapy and treatment of liver metastases. Sir-Sphere therapy has been approved for treating colorectal cancer with liver metastases. The combination of cetuximab and irinotecan is FDA approved for metastatic colorectal cancer. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIR-Spheres + Therapy | Active comparator | Drug: SIR-spheres Agent Administration, Drug: Cetuximab, Drug: IrinotecanSIR-Spheres with Cetuximab + Irinotecan Therapy |
| Therapy Only | Active comparator | Drug: Cetuximab, Drug: IrinotecanCetuximab + Irinotecan Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Histology from the hepatic metastasis is not mandatory if the morphological appearances on cross sectional imaging and tumor markers (CEA) are indicative of a colorectal primary.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in two dimensions (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT scan.
- Patients must have radiological evidence of disease progression of disease within 6 months of their most recent dose of chemotherapeutic regimens .
- Age greater than or equal to 18 years.
- ECOG performance status less than or equal to 2.
Key exclusion criteria (9 listed)
- Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier will be excluded. Patients who have had hepatic external beam radiotherapy will be excluded.
- Patients may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to SIR-Spheres, irinotecan or cetuximab or other agents used in the study.
- Evidence of ascites, biopsy proven cirrhosis or portal hypertension suggested by the presence of characteristic imaging features on cross sectional imaging or esophageal varicosities demonstrated on endoscopy or barium swallow. A diagnostic study to rule out the presence of portal hypertension will not be required unless the findings on cross sectional imaging are suggestive but not confirmatory.
- Hepatic arterial anatomy that would prevent catheterization and the administration of SIR-Spheres into the liver.
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 |
|---|---|---|
| SIR-spheres Agent AdministrationAlso: Yttrium-90, Yttrium 90, Yttrium microspheresSIR-Spheres, resin microspheres containing pure Beta emitter Yttrium-90, given through femoral catheter over 10 minutes. | Drug | SIR-Spheres + Therapy |
| CetuximabAlso: C225, Erbitux™, IMC-C225400 mg/m2 by vein over 2 hours once a week. Cetuximab infusions will be continued weekly at a dose of 250 mg/m2 unless toxicity necessitates interruptions. | Drug | SIR-Spheres + Therapy, Therapy Only |
| IrinotecanAlso: CPT-11350 mg/m2 (or 300 mg/m2 in patients who are greater or equal to 70 years of age, or have an ECOG PS of 2 or have had prior pelvic and/or abdominal irradiation), by vein over 90 minutes, every three weeks. | Drug | SIR-Spheres + Therapy, Therapy Only |
Primary outcome
Progression Free Survival
Time frame: 4 Months
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 3 Jan 2013.
- MD Anderson Cancer Center websiteLink provided by the sponsor.
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Ravi Murthy, MD principal investigator
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SIR-spheres Agent Administration, Cetuximab and Irinotecan in people with Colon Cancer and Colorectal Cancer, run by M.D. Anderson Cancer Center.
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 12 inclusion and 9 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 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Progression Free Survival (time frame: 4 Months). 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 3 Jan 2013.