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

King Faisal Specialist Hospital & Research Center

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Docetaxel + Standard dose Vitamin D2; Drug: Docetaxel + High dose Vitamin D2

Study type: Interventional

Funder types: Other

Identifiers

NCT00944424

RAC # 2091-009

Details and patient eligibility

About

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

Full description

2 Arms Randomization in patients with metastatic breast cancer.

Arm A = Docetaxel + High dose Vitamin D2

Arm B = Docetaxel + Standard dose Vitamin D2

Enrollment: 260 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 2 patient groups

Arm A

Experimental group

Description:

Arm A = Docetaxel + High dose Vitamin D2

Treatment:

Drug: Docetaxel + High dose Vitamin D2

Arm B

Active Comparator group

Description:

Docetaxel + Standard dose Vitamin D2

Treatment:

Drug: Docetaxel + Standard dose Vitamin D2