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Clinical Trials/NCT00944424
NCT00944424
Unknown
Phase 3

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

King Faisal Specialist Hospital & Research Center6 sites in 3 countries260 target enrollmentStarted: July 2009Last updated:
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ConditionsBreast Cancer
InterventionsDocetaxel + High dose Vitamin D2Docetaxel + Standard dose Vitamin D2
DrugsDocetaxel + High dose Vitamin D2Docetaxel + Standard dose Vitamin D2

Overview

Phase
Phase 3
Enrollment
260
Locations
6
Primary Endpoint
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.
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

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.

Arms & Interventions

Arm A

Experimental

Arm A = Docetaxel + High dose Vitamin D2

Intervention: Docetaxel + High dose Vitamin D2 (Drug)

Arm B

Active Comparator

Docetaxel + Standard dose Vitamin D2

Intervention: Docetaxel + Standard dose Vitamin D2 (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

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