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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Docetaxel + High dose Vitamin D2

Docetaxel + Standard dose Vitamin D2

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Vitamin D in patients with metastatic breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

Kuwait Cancer Center
King Faisal Specialist Hospital & Research CenterRecruiting
King Abdulaziz Hospital and Oncology Center
King Abdulaziz Medical City
King Fahad Medical City
Tawam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Arm A = Docetaxel + High dose Vitamin D2

Docetaxel + Standard dose Vitamin D2

Outcomes

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.

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.

Full Information

NCT ID

NCT00944424

First Posted

July 22, 2009

Last Updated

December 11, 2011

Sponsor

King Faisal Specialist Hospital & Research Center

1. Study Identification

Unique Protocol Identification Number

NCT00944424

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Unknown status

Study Start Date

July 2009 (undefined)

Primary Completion Date

July 2012 (Anticipated)

Study Completion Date

July 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

King Faisal Specialist Hospital & Research Center

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Vitamin D in patients with metastatic breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Arm A = Docetaxel + High dose Vitamin D2

Arm Title

Arm B

Arm Type

Active Comparator

Arm Description

Docetaxel + Standard dose Vitamin D2

Intervention Type

Drug

Intervention Name(s)

Docetaxel + High dose Vitamin D2

Intervention Description

Docetaxel + High dose Vitamin D2

Intervention Type

Drug

Intervention Name(s)

Docetaxel + Standard dose Vitamin D2

Intervention Description

Docetaxel + Standard dose Vitamin D2

Primary Outcome Measure Information:

Title

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Taher Tweigeri, MD

Phone

0096614647272

Ext

38047

ttwegieri@kfshrc.edu.sa

First Name & Middle Initial & Last Name or Official Title & Degree

Romelia Retuta

Phone

966-1-4647272

Ext

32957

romelia@kfshrc.edu.sa

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Taher Al-Tweigeri, MD

Organizational Affiliation

KFSHRC

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dahish Ajarim, MD

Organizational Affiliation

KFSHRC

Official's Role

Study Director

Facility Information:

Facility Name

Kuwait Cancer Center

City

Kuwait City

Country

Kuwait

Individual Site Status

Not yet recruiting

Facility Name

King Faisal Specialist Hospital & Research Center

City

Riyadh

State/Province

Central

ZIP/Postal Code

11211

Country

Saudi Arabia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Taher Al-Tweigeri, MD

First Name & Middle Initial & Last Name & Degree

Dahish Ajarim, MD

First Name & Middle Initial & Last Name & Degree

Adher Al-Sayed, MD

First Name & Middle Initial & Last Name & Degree

Mohammad Al-Shabanah, MD

Facility Name

King Abdulaziz Hospital and Oncology Center

City

Jeddah

Country

Saudi Arabia

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tarek Darwish, MD

Facility Name

King Abdulaziz Medical City

City

Riyadh

Country

Saudi Arabia

Individual Site Status

Not yet recruiting

Facility Name

King Fahad Medical City

City

Riyadh

Country

Saudi Arabia

Individual Site Status

Not yet recruiting

Facility Name

Tawam Hospital

City

Al Ain City

Country

United Arab Emirates

Individual Site Status

Not yet recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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