Phase III Trial of High Dose vs. Standard Dose Vit D2 With Docetaxel in Met Breast ca

Breast Cancer Clinical Trial

— GORG-002  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00944424
• Other study ID #: RAC # 2091-009
• Status: Recruiting
• Phase: Phase 3
• First received: July 22, 2009
• Last updated: December 11, 2011
• Start date: July 2009
• Est. completion date: July 2012

Study information

• Verified date: December 2011
• Source: King Faisal Specialist Hospital & Research Center
• Contact: Taher Tweigeri, MD
• Phone: 0096614647272
• Email: ttwegieri[@]kfshrc.edu.sa
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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

Description:

2 Arms Randomization in patients with metastatic breast cancer.

Arm A = Docetaxel + High dose Vitamin D2

Arm B = Docetaxel + Standard dose Vitamin D2

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Docetaxel + High dose Vitamin D2
Docetaxel + High dose Vitamin D2
• Docetaxel + Standard dose Vitamin D2
Docetaxel + Standard dose Vitamin D2

Locations

Country	Name	City	State
Kuwait	Kuwait Cancer Center	Kuwait City
Saudi Arabia	King Abdulaziz Hospital and Oncology Center	Jeddah
Saudi Arabia	King Abdulaziz Medical City	Riyadh
Saudi Arabia	King Fahad Medical City	Riyadh
Saudi Arabia	King Faisal Specialist Hospital & Research Center	Riyadh	Central
United Arab Emirates	Tawam Hospital	Al Ain City

Sponsors (1)

Lead Sponsor	Collaborator
King Faisal Specialist Hospital & Research Center

Countries where clinical trial is conducted

Kuwait,  Saudi Arabia,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year	Yes
Secondary	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.		1 year	Yes