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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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


2 Arms Randomization in patients with metastatic breast cancer.

Arm A = Docetaxel + High dose Vitamin D2

Arm B = Docetaxel + Standard dose Vitamin D2


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).

Type of Study:

Interventional

Study Design:

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

Outcome 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.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Taher Al-Tweigeri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

KFSHRC

Authority:

United States: Institutional Review Board

Study ID:

RAC # 2091-009

NCT ID:

NCT00944424

Start Date:

July 2009

Completion Date:

July 2012

Related Keywords:

  • Breast Cancer
  • Vitamin D in patients with metastatic breast cancer
  • Breast Neoplasms

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