NCT00944424

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_3 breast-cancer

Geographic Reach
3 countries

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 13, 2011

Status Verified

December 1, 2011

Enrollment Period

3 years

First QC Date

July 22, 2009

Last Update Submit

December 11, 2011

Conditions

Breast Cancer

Keywords

Vitamin D in patients with metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Arm A

EXPERIMENTAL

Arm A = Docetaxel + High dose Vitamin D2

Drug: Docetaxel + High dose Vitamin D2

Arm B

ACTIVE COMPARATOR

Docetaxel + Standard dose Vitamin D2

Drug: Docetaxel + Standard dose Vitamin D2

Interventions

Docetaxel + High dose Vitamin D2DRUG

Docetaxel + High dose Vitamin D2

Arm A
Docetaxel + Standard dose Vitamin D2DRUG

Docetaxel + Standard dose Vitamin D2

Arm B

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven metastatic adenocarcinoma of the breast.
  • Gender: female.
  • Age ≥18 years.
  • ECOG performance status ≤ 2.(see appendix I)
  • (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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Kuwait Cancer Center

Kuwait City, Kuwait

NOT YET RECRUITING

King Faisal Specialist Hospital & Research Center

Riyadh, Central, 11211, Saudi Arabia

RECRUITING

King Abdulaziz Hospital and Oncology Center

Jeddah, Saudi Arabia

NOT YET RECRUITING

King Abdulaziz Medical City

Riyadh, Saudi Arabia

NOT YET RECRUITING

King Fahad Medical City

Riyadh, Saudi Arabia

NOT YET RECRUITING

Tawam Hospital

Al Ain City, United Arab Emirates

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DocetaxelErgocalciferols

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Taher Al-Tweigeri, MD

    KFSHRC

    PRINCIPAL INVESTIGATOR

  • Dahish Ajarim, MD

    KFSHRC

    STUDY DIRECTOR

Central Study Contacts

Taher Tweigeri, MD

CONTACT

0096614647272ttwegieri@kfshrc.edu.sa

Romelia Retuta

CONTACT

966-1-4647272romelia@kfshrc.edu.sa

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 23, 2009

Study Start

July 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

December 13, 2011

Record last verified: 2011-12

Locations

KU(1)SA(4)AE(1)