Clinical trial NCT00944424: Phase III Trial of High Dose vs. Standard Dose Vit D2 With Docetaxel in Met Breast ca
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Vitamin D in patients with metastatic breast cancer
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2009-07-23
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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).

Primary outcomes:
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.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Kuwait City
country: Kuwait
facility: Kuwait Cancer Center
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
state: Central
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz Hospital and Oncology Center
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
city: Al Ain City
country: United Arab Emirates
facility: Tawam Hospital
Study officials:
affiliation: KFSHRC
name: Taher Al-Tweigeri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: KFSHRC
name: Dahish Ajarim, MD
role: STUDY_DIRECTOR
References: