Breast CancerPhase 3GORG-002NCT00944424
Phase III Trial of High Dose vs. Standard Dose Vit D2 With Docetaxel in Met Breast ca
A Phase 3 study testing Docetaxel + High dose Vitamin D2 and Docetaxel + Standard dose Vitamin D2 in people with Breast Cancer, run by King Faisal Specialist Hospital & Research Center at 6 sites in 3 countries.
Trial summary
Randomized phase III trial to determine the effectiveness of High dose versus Standard dose of Vitamin D2 (Ergocalciferol) given with Docetaxel in patients with metastatic breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Docetaxel + High dose Vitamin D2 and Docetaxel + Standard dose Vitamin D2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jul 2009to Jul 2012
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven metastatic adenocarcinoma of the breast.
- Gender: female.
- Age ≥18 years.
- ECOG performance status ≤ 2.(see appendix I)
- 25 (OH) Vitamin D level ≤ 100nmol/L (40ng/L).
- No more than 1 prior chemotherapy regimen not including Docetaxel or Paclitaxel for metastatic breast cancer.
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- Patients progressed on Doxorubicin or epirubicin as first line for metastatic breast cancer is eligible.
- Concurrent bisphosphonate therapy allowed.
- Life expectancy more than 6 months
- At least 12 months since prior adjuvant or neo-adjuvant chemotherapy including Taxanes regimens.
- Adequate hematologic, hepatic and renal function.
- Written informed consent.
Who cannot join
- Pregnant or lactating women.
- Male breast cancer.
- Women of childbearing potential unless surgically sterile or using adequate measures of contraception.
- Metastatic inflammatory breast cancer.
- CNS metastasis.
- Leptomeningeal carcinomatosis.
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- Malignant hypercalcemia.
- History of kidney stones.
- History of active primary hyperparathyroidism.
- Normal 25 (OH) Vitamin D level ≥100 nmol/L or ≥ 40 ng/L.
- Previous or concomitant malignancy of any type, except adequately treated basal cell carcinoma of the skin or in situ cervix cancer.
- Patient on any anti-Psychotic medications or Steroid therapy.
- History of malabsorption syndrome (pancreatic insufficiency, celiac disease and tropical sprue).
- Any of the following abnormal baseline hematological values:
- ANC < 1.0 x109/L, or platelets < 100.000 x 109/L.
- Any of the following abnormal laboratory tests: total serum bilirubin >2.00 x ULN (upper limit of normal), AST, ALT > 2.5 x ULN or ALP >2.50 x ULN (upper limit of normal).
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Saudi Arabia4 sites, 4 recruiting
- Not yet recruiting
King Abdulaziz Hospital and Oncology Center
Jeddah
Tarek Darwish, MD
- Recruiting
King Faisal Specialist Hospital & Research Center
Riyadh, Central, 11211
Taher Al-Tweigeri, MD
Dahish Ajarim, MD
- Not yet recruiting
King Abdulaziz Medical City
Riyadh
- Not yet recruiting
King Fahad Medical City
Riyadh
United Arab Emirates1 site, 1 recruiting
- Not yet recruiting
Tawam Hospital
Al Ain City
About this study
Official title: GORG - 002 Randomized Phase III Trial to Determine the Effectiveness of High Dose Versus Standard Dose of Vitamin D2 (Ergocalciferol) Given With Docetaxel in Patients With Metastatic Breast Cancer
Randomized phase III trial to determine the effectiveness of High dose versus Standard dose of Vitamin D2 (Ergocalciferol) given with Docetaxel in patients with metastatic breast cancer
Read the detailed description
2 Arms Randomization in patients with metastatic breast cancer.
Arm A = Docetaxel + High dose Vitamin D2
Arm B = Docetaxel + Standard dose Vitamin D2
- Conditions
- Breast Cancer
- Being tested
- Docetaxel + High dose Vitamin D2, Docetaxel + Standard dose Vitamin D2
- Keywords
- Vitamin D in patients with metastatic breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel + High dose Vitamin D2Drug
Docetaxel + High dose Vitamin D2
Docetaxel + Standard dose Vitamin D2Drug
Docetaxel + Standard dose Vitamin D2
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Arm A = Docetaxel + High dose Vitamin D2 Receives: Drug: Docetaxel + High dose Vitamin D2 |
| Arm B | Active comparator | Docetaxel + Standard dose Vitamin D2 Receives: Drug: Docetaxel + Standard dose Vitamin D2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression is from the start of Docetaxel to disease progression. Patients who have not progressed at the time of study completion or who are lost to follow-up are censored at the last Vitamin D administration date.
Measured: 1 year
Secondary outcomes (1)
Overall survival is defined as the time from start of Docetaxel to death due to any cause. Patients for whom no death is captured on the clinical database are censored at the last date they were known to be alive.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taher Al-Tweigeri, MD, Principal investigator, KFSHRCDahish Ajarim, MD, Study director, KFSHRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944424
- Sponsor's protocol ID
- RAC # 2091-009
- Acronym
- GORG-002
- Status last verified
- Dec 2011
- First submitted
- 22 Jul 2009
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GORG - 002 Randomized Phase III Trial to Determine the Effectiveness of High Dose Versus Standard Dose of Vitamin D2 (Ergocalciferol) Given With Docetaxel in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00944424
- Acronym / sponsor ID
- GORG-002 / RAC # 2091-009
- Conditions
- Breast Cancer
- Keywords
- Vitamin D in patients with metastatic breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 23 Jul 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.
Randomized phase III trial to determine the effectiveness of High dose versus Standard dose of Vitamin D2 (Ergocalciferol) given with Docetaxel in patients with metastatic breast cancer
Detailed description
2 Arms Randomization in patients with metastatic breast cancer.
Arm A = Docetaxel + High dose Vitamin D2
Arm B = Docetaxel + Standard dose Vitamin D2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Docetaxel + High dose Vitamin D2Arm A = Docetaxel + High dose Vitamin D2 |
| Arm B | Active comparator | Drug: Docetaxel + Standard dose Vitamin D2Docetaxel + Standard dose Vitamin D2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically proven metastatic adenocarcinoma of the breast.
- Gender: female.
- Age ≥18 years.
- ECOG performance status ≤ 2.(see appendix I)
- 25 (OH) Vitamin D level ≤ 100nmol/L (40ng/L).
Key exclusion criteria (16 listed)
- Pregnant or lactating women.
- Male breast cancer.
- Women of childbearing potential unless surgically sterile or using adequate measures of contraception.
- Metastatic inflammatory breast cancer.
- CNS metastasis.
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 |
|---|---|---|
| Docetaxel + High dose Vitamin D2Docetaxel + High dose Vitamin D2 | Drug | Arm A |
| Docetaxel + Standard dose Vitamin D2Docetaxel + Standard dose Vitamin D2 | Drug | Arm B |
Primary outcome
Time to progression is from the start of Docetaxel to disease progression. Patients who have not progressed at the time of study completion or who are lost to follow-up are censored at the last Vitamin D administration date.
Time frame: 1 year
1 secondary outcome
Overall survival is defined as the time from start of Docetaxel to death due to any cause. Patients for whom no death is captured on the clinical database are censored at the last date they were known to be alive.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
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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.
Taher Al-Tweigeri, MD principal investigator
KFSHRC
Dahish Ajarim, MD study director
KFSHRC
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel + High dose Vitamin D2 and Docetaxel + Standard dose Vitamin D2 in people with Breast Cancer, run by King Faisal Specialist Hospital & Research Center at 6 sites in 3 countries.
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 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: status not confirmed, as of the sponsor's last update on 13 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Saudi Arabia, Kuwait, United Arab Emirates. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taher Tweigeri, MD (0096614647272 ext. 38047, ttwegieri@kfshrc.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression is from the start of Docetaxel to disease progression. Patients who have not progressed at the time of study completion or who are lost to follow-up are censored at the last Vitamin D administration date. (time frame: 1 year). 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 13 Dec 2011.