Status:
UNKNOWN
Phase III Trial of High Dose vs. Standard Dose Vit D2 With Docetaxel in Met Breast ca
Lead Sponsor:
King Faisal Specialist Hospital & Research Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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
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
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- 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).
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00944424
Start Date
July 1 2009
End Date
July 1 2012
Last Update
December 13 2011
Active Locations (6)
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1
Kuwait Cancer Center
Kuwait City, Kuwait
2
King Faisal Specialist Hospital & Research Center
Riyadh, Central, Saudi Arabia, 11211
3
King Abdulaziz Hospital and Oncology Center
Jeddah, Saudi Arabia
4
King Abdulaziz Medical City
Riyadh, Saudi Arabia