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

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

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Docetaxel + High dose Vitamin D2; Drug: 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

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Taher Tweigeri, MD; Phone Number: 38047 0096614647272; Email: ttwegieri@kfshrc.edu.sa
• Study Contact Backup: Name: Romelia Retuta; Phone Number: 32957 966-1-4647272; Email: romelia@kfshrc.edu.sa

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: King Faisal Specialist Hospital & Research Center
• Investigators: Principal Investigator: Taher Al-Tweigeri, MD, KFSHRC; Study Director: Dahish Ajarim, MD, KFSHRC

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: July 22, 2009
• First Submitted That Met QC Criteria: July 22, 2009
• First Posted (Estimate): July 23, 2009

Study Record Updates

• Last Update Posted (Estimate): December 13, 2011
• Last Update Submitted That Met QC Criteria: December 11, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Vitamin D in patients with metastatic breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Docetaxel; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: RAC # 2091-009