NCT00846612

Brief Summary

This study is to study pharmacokinetics of Doxil using Doxil and Avastin on ovarian cancer patients who are resistant to or have relapsed from platinum-based therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1 ovarian-cancer

Timeline
Completed

Started Jan 2008

Typical duration for phase_1 ovarian-cancer

Geographic Reach
1 country

4 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

January 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

2.7 years

First QC Date

February 18, 2009

Last Update Submit

September 26, 2019

Conditions

Ovarian Cancer

Keywords

refractoryavastindoxilrelapsedovarian cancerplatinum-resistant

Outcome Measures

Primary Outcomes (1)

  • change in peak plasma concentration of Doxil without and with Avastin

    In cycle 1, patients were treated only with Doxil; in cycle 2, patients were treated with Doxil and Avastin.

    1 hour, 1, 4, 7, 10, 14, and 21 days post-dose in cycle 1 and cycle 2

Study Arms (1)

Avastin-Doxil

EXPERIMENTAL
Drug: DoxilDrug: Bevacizumab (Avastin)

Interventions

DoxilDRUG

1 cycle: 3 weeks; 30 mg/m\^2, IV, every cycle

Also known as: pegylated doxorubicin liposome
Avastin-Doxil
Bevacizumab (Avastin)DRUG

1 cycle: every 3 weeks; 15 mg/kg, IV, beginning on cycle 2 and every cycle 20-24 hours following Doxil administration

Also known as: Avastin
Avastin-Doxil

Eligibility Criteria

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

You may qualify if:

  • Patients must be platinum resistant
  • No prior anthracycline use
  • PS ≤ 2
  • Lab values within certain limits (ANC \> 1000, platelets \> 100,000; ALT, AST 2x ULN, creatinine \< 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
  • \> 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 greater than 150 and/or diastolic blood pressure \> 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 of the protocol)
  • 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 (4)

Univ. of New Mexico cancer research and treatment center

Albuquerque, New Mexico, 87131, United States

Location

Bellevue Hospital

New York, New York, 10016, United States

Location

NYU Cancer Center

New York, New York, 10016, United States

Location

NYU medical center (Tisch Hospital)

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsRecurrence

Interventions

liposomal doxorubicinBevacizumab

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 DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Franco Muggia, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

January 1, 2008

Primary Completion

September 1, 2010

Study Completion

June 1, 2012

Last Updated

September 30, 2019

Record last verified: 2019-09

Locations

US(4)