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Oral Vinorelbine in Combination With Trastuzumab for Metastatic Breast Cancer (OVINTRA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01242449
First received: November 16, 2010
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

This phase II study will investigate oral vinorelbine 90 mg/m2 on days 1 + 8 at 3 weeks intervals in combination with trastuzumab as 1st and 2nd line treatment of women with metastatic HER2 positive breast cancer.

Oral vinorelbine has shown the same overall response rate as i.v. vinorelbine in metastatic breast cancer, and capsules are generally better tolerated.


Condition Intervention Phase
Breast Cancer
Drug: Trastuzumab
Drug: Vinorelbine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Investigation of Oral Vinorelbine in Combination With Trastuzumab for 1st and 2nd Line Treatment of Women With Metastatic HER2 Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: Every 9 weeks. Up to 2 years ] [ Designated as safety issue: No ]
    CT scan and MUGA scan


Secondary Outcome Measures:
  • Progression free survival [ Time Frame: Every 9 weeks from date of first treatment until progression or death. Up to 2 years ] [ Designated as safety issue: No ]
    CT scan

  • Overall Survival [ Time Frame: From date of inclusion until date of death. Up to 2 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2010
Estimated Study Completion Date: October 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Trastuzumab
    Initial dose 8 mg/kg i.v. Subsequently, 6 mg/kg i.v. at intervals of 3 weeks
    Drug: Vinorelbine
    Initial dose 70 mg/m2 on days 1 and 8 (capsules) If well tolerated, subsequently 90 mg/m2 on days 1 and 8. Capsule on day 1 to be taken at the hospital, and on day 8 at home.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Woman ≥ 18 years of age.
  • PS 0-2. Expected lifetime of more than 12 weeks.
  • Histologically verified breast cancer(adenocarcinoma)
  • Primary tumor or metastasis is HER2 positive with IHC3+ or FISH+ (ratio ≥ 2.2).
  • Documented metastatic breast cancer with min. one lesion measureable according to the RECIST 1.1 criteria. All solitary lesions must be verified cytologically/histologically if representing the only evidence of malignancy.
  • The patient may have received (neo-) adjuvant chemotherapy (taxanes, anthracyclines and trastuzumab) and 1st line chemotherapy in combination with trastuzumab for metastatic disease.
  • The patient may have received previous adjuvant antihormonal treatment for metastatic breast cancer.
  • The patient may receive radiation therapy, however, not against lesions used for response evaluation.
  • Normal heart function, LVEF ≥ 50% measured by MUGA/EKKO.
  • Normal bone marrow function: Hemoglobin ≥ 6 mmol/l, ANC ≥ 1.5x10^9/l. Thrombocytes ≥ 100x10^9/l.
  • Normal liver function: Bilirubin ≤ 1.5 x upper normal level, ALAT ≤ 2.5 x upper normal level, BASP ≤ 2.5 x upper normal level (≤ 5 if presence of bone metastases).
  • Normal renal function: Creatinine ≤ upper normal level. In case of raised creatinine the measured/calculated GFR must be ≥ 50 ml/min.
  • Fertile women must present a negative pregnancy test and use contraceptives during and 3 months after treatment. An IUD without hormone is considered a safe contraceptive.
  • Written and orally informed consent prior to any study related procedure.

Exclusion Criteria:

  • Local recurrence or counter-lateral breast cancer without other dissemination.
  • Pregnant or breastfeeding women.
  • Clinical symptoms of CNS metastases, incl. meningeal carcinomatosis.
  • Malabsorption syndrome or other disease affecting the gastrointestinal function. Resection of the ventriculus or the small intestine, which can affect absorption of oral vinorelbine.
  • Dysphagia or other conditions preventing the patient from swallowing tablets.
  • Mental or social conditions preventing treatment or follow-up.
  • Serious concurrent medical condition, such as:

    • AMI within 12 months or unstable angina.
    • Heart incompensation NYHA III or IV or uncontrolled hypertension (systolic > 150 mm/hg and/or diastolic >100 mm/hg).
    • Serious arrythmia requiring medication, excl. atrial fibrillation and paroxystic supraventricular tachycardia.
    • Active infection, uncontrolled diabetes or hypercalcemia.
  • Other concurrent experimental treatment.
  • Concurrent antihormonal treatment of metastatic breast cancer.
  • Known neuropathia ≥ grade 2.
  • Other previous malignant disease within the past 5 years excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri.
  • Previous treatment with vinca alkaloid.
  • Previous serious allergic or unexpected reactions to trastuzumab treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242449

Locations
Denmark
Dept. of Oncology, Aalborg Sygehus
Aalborg, Denmark, 9000
Dept. of Oncology, Esbjerg Hospital
Esbjerg, Denmark, 6700
Department of Oncology, Vejle Hospital
Vejle, Denmark, DK-7100
Sponsors and Collaborators
Vejle Hospital
Investigators
Principal Investigator: Troels Bechmann, MD Department of Oncology, Vejle Hospital
Study Chair: Erik H Jakobsen, MD Department of Oncology, Vejle Hospital
  More Information

No publications provided

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT01242449     History of Changes
Other Study ID Numbers: 2010-021618-42
Study First Received: November 16, 2010
Last Updated: March 28, 2014
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Vejle Hospital:
Breast cancer
Metastatic
HER2 positive
vinorelbine

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Trastuzumab
Vinorelbine
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014