Phase III Trial of High Dose vs. Standard Dose Vit D2 With Docetaxel in Met Breast ca (GORG-002)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by King Faisal Specialist Hospital & Research Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT00944424
First received: July 22, 2009
Last updated: December 11, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: Docetaxel + High dose Vitamin D2
Drug: Docetaxel + Standard dose Vitamin D2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 260
Study Start Date: July 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Arm A = Docetaxel + High dose Vitamin D2
Drug: Docetaxel + High dose Vitamin D2
Docetaxel + High dose Vitamin D2
Active Comparator: Arm B
Docetaxel + Standard dose Vitamin D2
Drug: Docetaxel + Standard dose Vitamin D2
Docetaxel + Standard dose Vitamin D2

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944424

Contacts
Contact: Taher Tweigeri, MD 0096614647272 ext 38047 ttwegieri@kfshrc.edu.sa
Contact: Romelia Retuta 966-1-4647272 ext 32957 romelia@kfshrc.edu.sa

Locations
Kuwait
Kuwait Cancer Center Not yet recruiting
Kuwait City, Kuwait
Saudi Arabia
King Faisal Specialist Hospital & Research Center Recruiting
Riyadh, Central, Saudi Arabia, 11211
Principal Investigator: Taher Al-Tweigeri, MD         
Principal Investigator: Dahish Ajarim, MD         
Sub-Investigator: Adher Al-Sayed, MD         
Sub-Investigator: Mohammad Al-Shabanah, MD         
King Abdulaziz Hospital and Oncology Center Not yet recruiting
Jeddah, Saudi Arabia
Principal Investigator: Tarek Darwish, MD         
King Fahad Medical City Not yet recruiting
Riyadh, Saudi Arabia
King Abdulaziz Medical City Not yet recruiting
Riyadh, Saudi Arabia
United Arab Emirates
Tawam Hospital Not yet recruiting
Al Ain City, United Arab Emirates
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Taher Al-Tweigeri, MD KFSHRC
Study Director: Dahish Ajarim, MD KFSHRC
  More Information

No publications provided

Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT00944424     History of Changes
Other Study ID Numbers: RAC # 2091-009
Study First Received: July 22, 2009
Last Updated: December 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by King Faisal Specialist Hospital & Research Center:
Vitamin D in patients with metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vitamin D
Ergocalciferols
Vitamins
Docetaxel
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014