Biweekly Avastin and Docetaxel as the First Line Treatment for Patients With Metastatic Breast Cancer (AINO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Tampere University Hospital
Sponsor:
Collaborators:
Oulu University Hospital
Turku University Hospital
Information provided by (Responsible Party):
Pirkko-Liisa Kellokumpu-Lehtinen, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT00979641
First received: December 19, 2008
Last updated: February 5, 2014
Last verified: March 2012
  Purpose

The purpose of this study is to evaluate the efficacy and safety of the combination of biweekly docetaxel and bevacizumab in the first line treatment of metastatic breast cancer by using Response Evaluation Criteria In Solid Tumors (RECIST criteria) and NCI Common Terminology Criteria for Adverse Events (NCI CTC-AE) version 3. In addition several biochemical makers are tested as possible predictive factors.


Condition Intervention Phase
Neoplasms
Drug: bevacizumab plus docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Arm Study of the Combination of Biweekly Avastin and Docetaxel as the First Line Treatment for Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • progression free survival [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • efficacy [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 2- 3 months ] [ Designated as safety issue: No ]
  • time to response [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • duration of response [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • progression free survival from first relapse [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • safety [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 65
Study Start Date: January 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chemotherapy
i.v. biweekly bevacizumab 10 mg/kg and docetaxel 50 mg/square meter
Drug: bevacizumab plus docetaxel
i.v. bevacizumab 10 mg/kg and docetaxel 50 mg/square meter, q2w
Other Name: no other names

Detailed Description:

Patients with histologically or cytologically proven measurable or nonmeasurable metastatic breast cancer are treated with a combination of biweekly docetaxel and bevacizumab as the first line treatment in multicenter phase II trial. The outcome measures would be PFS, Response rate (RECIST), duration of response, safety (NCI CTC-AE version 3) and survival. In addition several biochemical makers are tested as possible predictive factors. Treatment would be continued until PD, patient's refusal or treatment discontinuation due to side-effects or patients death. In responding patients bevacizumab would be continued either alone or in hormone receptor positive patients combined with hormone treatment until progression.

  Eligibility

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

Inclusion Criteria:

  • written informed concent
  • age > or equal 18 years
  • able to comply with the protocol
  • histologically or cytologically confirmed, Her-2 negative, adenocarcinoma of the breast with measurable or nonmeasurable metastatic disease, chemotherapy indicated
  • ECOG 0-2, life expectancy of over or qual to 12 wks
  • prior neo/adjuvant chemotherapy allowed
  • prior adjuvant taxane therapy is allowed, DFS> or equal 6 months
  • previous hormonal therapy allowed
  • prior RT is allowed as adjuvant setting or to relief of metastatic bone pain, no more than 30% of marrow-bearing bone irradiated
  • Adequate haematological function
  • adequate liver function total bilirubin <1.5 x upper limit of normal and AST,ALT <2.5 x ULN in patients without liver metastases; <5 x ULN in patients with liver metastases
  • adequate renal function serum creatinine <or equal 1,5x ULN or calculated creatinine clearance > or equal 50mL/min and urine dipstick for proteinuria <2+. Patients discovered to have or equal proteinuria or dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate < or equal 1 g of protein in 24 hours
  • INR<or equal 1.5 and PTT< or equal 1.5 x ULN within 7 days prior to enrolment. Anticoagulation treatment not allowed
  • if female, should not be pregnant or breast-feeding. Women with an intact uterus must have a negative serum pregnancy test within 28 days prior to inclusion into the study

Exclusion Criteria:

  • previous chemotherapy for mBC
  • radiation therapy for the treatment of metastatic disease within 28 days
  • evidence of CNS metastases. If symptomatic, the patient should be scanned within 28 days to enrolment to rule out CNS metastases
  • pre-existing peripheral neuropathy NCI CTC-AE grade > 2 at enrolment
  • major surgery, significant traumatic injury within 28 days prior to enrolment or anticipation of the need for major surgery during study treatment
  • Minor surgery, including insertion off an indwelling catheter, within 24 hours prior to the first line bevacizumab infusion
  • Current or recent(within 10 daÿs of first dose of bevacizumab) use of aspirin (>325mg/day)
  • current or recent (within 10 days of first dose of bevacizumab) use of oral or parenteral anticoagulants or thrombolytic agents.
  • history of evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
  • uncontrolled hypertension (systolic >150mmHg and/or diastolic>100mmHg)
  • Clinically significant cardiovascular disease for example CVA, myocardial infarction, unstable angina, congestive heart failure NYHA Class > or equal II, serious cardiac arrhythmia requiring medication during the study, which might interfere with regularity of the study treatment, or not controlled by medication
  • non- healing wound, active peptic ulcer or bone fracture
  • history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
  • past of current history (within the last 5 years) of other malignancies except curatively treated basal and squamous cell carcinoma of the skin or in-situ carcinoma of the cervix
  • treatment with any other investigational agent, or participation in another clinical drug trial within 28 days prior to enrolment
  • evidence of any other disease, neurological, psychiatric or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
  • history of thrombotic disorders within last six months
  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: NCT00979641

Contacts
Contact: Pirkko-Liisa I Kellokumpu-Lehtinen, MD +358331163227 klpike@uta.fi
Contact: Minna Tanner, MD +358331167640 Minna.Tanner@uta.fi

Locations
Finland
Tampere Unviersity Hospital Recruiting
Tampere, Finland
Contact: Pirkko-liisa I Kellokumpu-Lehtinen, MD    +358331163227    klpike@uta.fi   
Contact: Minna Tanner, MD    +358331167640    Minna.Tanner@uta.fi   
Sponsors and Collaborators
Tampere University Hospital
Oulu University Hospital
Turku University Hospital
Investigators
Principal Investigator: Pirkko-Liisa I Kellokumpu-Lehtinen, MD Tampere University Hospital
  More Information

No publications provided

Responsible Party: Pirkko-Liisa Kellokumpu-Lehtinen, professor of oncology and radiotherapy, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT00979641     History of Changes
Other Study ID Numbers: EudraCT 2008-003527-24
Study First Received: December 19, 2008
Last Updated: February 5, 2014
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Tampere University Hospital:
breast cancer
metastatic
chemotherapy
bevacizumab
docetaxel
Phase II
first line chemotherapy
metastatic breast cancer patients

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Docetaxel
Bevacizumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014