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Trial record 86 of 1148 for:    Oral Cancer | ( Map: Canada )

Combining Doxycycline With Bone-Targeted Therapy in Patients With Metastatic Breast Cancer (OTT12-05)

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ClinicalTrials.gov Identifier: NCT01847976
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : September 5, 2019
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
The purpose of this study is to see if women with bone metastases from breast cancer will benefit from the addition of doxycycline to their standard bone-targeted therapy. Participants will be asked to take 100 mg of Doxycycline orally twice a day for 12 weeks. Blood and tissue collection will further define the mechanism of the benefits if there are any.

Condition or disease Intervention/treatment Phase
Pain Drug: Doxycycline Phase 2

Detailed Description:
Potential candidates for this trial must have received intravenous bisphosphonate therapy (i.e. pamidronate or zoledronic acid) or subcutaneous denosumab for at least 3 months. Baseline patient characteristics will be recorded and screening serum PTH (to rule out primary hyperparathyroidism) and vitamin D (25OH-vit D) will be recorded. In order to fulfill the study objectives, serum will be taken for CTX (fasting morning blood sample), P1NP and BSAP as well as for the optional translational studies (e.g. MMP and TIMP levels). Optional urine will be taken for NTX. Questionnaires will also be completed for symptoms (Brief pain inventory (BPI) [26] and FACT-BP [27]) and analgesic use (converted into an oral Morphine-equivalent dose). The serum, urine and questionnaire data will be collected at: baseline, weeks 4, 8, and 12. In addition, toxicity information and questions about the occurrence of skeletal related events will be performed at baseline, weeks 4, 8 and 12. At baseline and week 12 the patient will also have a bone marrow aspirate and trephine biopsy performed from the posterior iliac crest. These specimens will be used for ER, PR and Her2 analysis (by FISH) and markers of apoptosis (TUNEL) and proliferation (Ki67) and also for optional translational studies providing tumour cells are present.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial Exploring the Clinical and Correlative Effects of Combining Doxycycline With Bone-Targeted Therapy in Patients With Metastatic Breast Cancer
Study Start Date : August 2013
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Doxycycline
100 mg of Doxycycline orally twice a day for 12 weeks.
Drug: Doxycycline
Participants will be asked to take 100 mg of Doxycycline by mouth twice a day for 12 weeks.
Other Names:
  • Doryx®
  • Monodox®
  • Oracea®
  • Periostat®
  • Vibramycin®




Primary Outcome Measures :
  1. palliative benefit [ Time Frame: Weeks 4, 8 and 12 from starting study treatment ]
    The primary objective of this prospective study is to assess the palliative benefit (reflected through changes in validated pain scores and the bone resorption marker serum C-telopeptide) of adding doxycycline 100mg PO BID daily for 3 months to standard bone-targeted (i.e. intravenous bisphosphonate or subcutaneous denosumab) therapy in women with breast cancer and bone metastases.


Secondary Outcome Measures :
  1. changes to bone formation markers [ Time Frame: Weeks 4, 8 and 12 from starting study treatment ]
    Assess the effect of adding doxycycline for 3 months to standard bone-targeted (i.e. intravenous bisphosphonate or subcutaneous denosumab) therapy on the bone formation markers P1NP and Bone Specific Alkaline Phosphatase.


Other Outcome Measures:
  1. changes in biomarkers [ Time Frame: Weeks 4, 8 and 12 from the start of study treatment ]
    To determine whether levels of FAK, MMPs or TIMPs correlate with palliative benefit, bone turnover, or symptom response in patients treated with doxycycline in combination with bone-targeted (i.e. intravenous bisphosphonate or subcutaneous denosumab) as compared to bone-targeted agent alone. This will be determined following a comparison of levels in baseline specimens (when patients are on bone-targeted agent alone) with end of study specimens (when patients are receiving both doxycycline and bone-targeted agents).



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with metastatic breast cancer with radiologically confirmed bone metastases.
  2. On intravenous bone-targeted therapy (bisphosphonate or subcutaneous (SC) denosumab) for at least 3 months.
  3. ECOG ≤ 2
  4. Life expectancy >3 months.
  5. No changes in the type of systemic chemotherapy, endocrine therapy or biological therapy (i.e. trastuzumab, lapatinib) treatment in the 4 weeks prior to study entry or anticipated changes in the 4 weeks after entering the study. (Markers of bone formation can be affected by a change in systemic therapies).
  6. Ability to provide informed consent and complete study evaluations.

Exclusion Criteria:

  1. Prior hypersensitivity to either IV bisphosphonate therapy or SC denosumab, doxycycline or tetracyclines.
  2. Patients with myasthenia gravis
  3. Patients taking hepatic enzymes inducers such as phenytoin, barbiturates and carbamazepine
  4. Patients with rapidly progressive non-bone metastases for whom delaying a change in systemic anti-cancer treatment in the first 4 weeks of the study could have a detrimental impact on patient outcome.
  5. Women of child bearing potential who are unwilling to use acceptable methods of contraception while on study.
  6. Pregnancy or lactation.
  7. Clotting disorder that would preclude bone marrow aspirate and trephine biopsy. (Patients on Fragmin or Daltaperin are allowed on study)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847976


Locations
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Canada, Ontario
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Breast Cancer Foundation
Investigators
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Principal Investigator: Mark Clemons, FRCP The Ottawa Hospital Cancer Centre

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01847976     History of Changes
Other Study ID Numbers: 20120543-02H
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ottawa Hospital Research Institute:
breast
bone pain
Additional relevant MeSH terms:
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Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents