NCT00945139

Brief Summary

The purpose of this research study is to test the safety, tolerability, and effectiveness of two chemotherapy drugs, pegylated liposomal doxorubicin (Doxil) and bevacizumab (Avastin). How Doxil is metabolized and excreted from the body will also be studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for phase_2 ovarian-cancer

Timeline
Completed

Started Mar 2007

Typical duration for phase_2 ovarian-cancer

Geographic Reach
1 country

3 active sites

Status
completed

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

March 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

July 7, 2015

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

3.8 years

First QC Date

July 21, 2009

Results QC Date

June 30, 2014

Last Update Submit

July 6, 2015

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

  • Progression Free Survival (PFS) by RECIST Criteria

    Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by hysical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Up to 25 months

  • Progression Free Survival (PFS) by GCIC Criteria

    Using GCIC criteria, progression is defined as CA-125 levels greater than, or equal to, 2 times the upper limit of a reference range on 2 occasions and at least 1 week apart.

    Up to 25 months

Secondary Outcomes (4)

  • Overall Survival

    4 years

  • Overall Response Rate (ORR) by RECIST

    3 years

  • Clinical Benefit Rate (by RECIST)

    3 years

  • Overall Response Rate (ORR) by GCIC Criteria

    3 years

Study Arms (1)

Single Arm: Doxil and Avastin

EXPERIMENTAL

Patients receive both agents, doxil and Avastin.

Drug: DoxilDrug: Avastin

Interventions

DoxilDRUG

Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1

Also known as: Doxorubicin
Single Arm: Doxil and Avastin
AvastinDRUG

First agent (Doxil) will be following by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression

Also known as: Bevacizumab
Single Arm: Doxil and Avastin

Eligibility Criteria

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

You may qualify if:

  • Patients must be platinum resistant
  • Patients will be included in the study based on the following criteria:
  • No prior anthracycline use
  • PS less or equal 2
  • Lab values within certain limits (ANC greater 1000, platelets greater 100,000; ALT, AST 2 time ULN, creatinine less 2.0)
  • No more than 3 prior chemotherapy regimens, only 2 of which can have included platinum-containing regimens
  • Use of effective means of contraception in subjects of child-bearing potential

You may not qualify if:

  • Evidence of complete or partial bowel obstruction
  • Need for IV hydration or TPN
  • Greater 2 prior abdominal surgeries
  • History of gastrointestinal perforation
  • Gastrointestinal perforation due to any other cause within the last 6 months
  • Inability to comply with study and/or follow-up procedures
  • Life expectancy of less than 12 weeks
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study
  • Inadequately controlled hypertension (defined as systolic blood pressure 150 and/or diastolic blood pressure greater 100 mmHg on antihypertensive medications)
  • Any prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix E)
  • History of myocardial infarction or unstable angina within 6 months prior to study enrollment
  • History of stroke or transient ischemic attack within 6 months prior to study enrollment
  • Known CNS disease
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

New Mexico Cancer Care Associates

Santa Fe, New Mexico, 87505, United States

Location

New York University Cancer Institute

New York, New York, 10016, United States

Location

Related Publications (1)

  • Verschraegen CF, Czok S, Muller CY, Boyd L, Lee SJ, Rutledge T, Blank S, Pothuri B, Eberhardt S, Muggia F. Phase II study of bevacizumab with liposomal doxorubicin for patients with platinum- and taxane-resistant ovarian cancer. Ann Oncol. 2012 Dec;23(12):3104-3110. doi: 10.1093/annonc/mds172. Epub 2012 Jul 31.

    PMID: 22851407RESULT

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

liposomal doxorubicinDoxorubicinBevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Dr. Claire Verschraegen
Organization
University of Vermont CC
claire.verschraegen@vtmednet.org
802-656-5487

Study Officials

  • Claire F. Verschraegen, M.D.

    University of New Mexico

    PRINCIPAL INVESTIGATOR

  • Franco Muggia, MD

    New York University Cancer Institute

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2009

First Posted

July 23, 2009

Study Start

March 1, 2007

Primary Completion

December 1, 2010

Study Completion

August 1, 2011

Last Updated

July 31, 2015

Results First Posted

July 7, 2015

Record last verified: 2015-07

Locations

US(3)