NCT00268918

Brief Summary

The main purpose of this study is to see if the study drug, PTK787, is safe and to find the highest dose that can be given safely without causing serious side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 ovarian-cancer

Timeline
Completed

Started Sep 2005

Typical duration for phase_1 ovarian-cancer

Geographic Reach
1 country

2 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

September 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

July 27, 2018

Status Verified

July 1, 2018

Enrollment Period

1.3 years

First QC Date

December 21, 2005

Last Update Submit

July 26, 2018

Conditions

Ovarian CancerEndometrial CancerCervical CancerFallopian Tube CancerPeritoneal CancerBreast Cancer

Keywords

PTK787Metastatic breast cancerRefractory gynecological cancer

Outcome Measures

Primary Outcomes (1)

  • To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787.

    2 years

Secondary Outcomes (1)

  • To estimate the preliminary efficacy of this combination in both metastatic breast cancer patients and refractory gynecological patients.

    2 years

Study Arms (1)

Docetaxel / PTK787

EXPERIMENTAL

Docetaxel: Lead In: Given intravenously on Day 1 and Day 14 Afer Lead in: Given intravenously on day 1, 8, 15, 22 of each 28-day cycle. PTK787: Lead In: Given orally on day 4 and day 14 After Lead In: Given orally once a day.

Drug: DocetaxelDrug: PTK787

Interventions

DocetaxelDRUG

Participants may continue receiving study drug as long as their disease does not worsen

Also known as: Taxotere
Docetaxel / PTK787
PTK787DRUG

Participants may continue receiving study drug as long as their disease does not worsen

Also known as: Vatalanib
Docetaxel / PTK787

Eligibility Criteria

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

You may qualify if:

  • Recurrent gynecological cancers or metastatic breast cancer. Initial diagnosis must be confirmed histologically.
  • Measurable disease or nonmeasurable disease
  • Age \> 18 years
  • ECOG performance 0,1,2
  • weeks or greater since major surgery, 3 weeks or greater since chemotherapy
  • Certain lab values
  • Negative for proteinuria

You may not qualify if:

  • Four or more treatment regimens
  • History or presence of uncontrolled CNS disease
  • Prior biologic or immunotherapies less than 3 weeks prior to registration
  • Prior full field radiotherapy less than 4 weeks or limited field radiotherapy less than 2 weeks prior to registration
  • Prior therapy with anti-VEGF agents
  • Peripheral neuropathy with functional impairment \> CTC grade 2
  • Pregnant or breast feeding
  • Concurrent severe and/or uncontrolled medical condition
  • Chronic renal disease
  • Acute or chronic liver disease
  • Impairment of gastrointestinal function or GI disease
  • Confirmed diagnosis of HIV infection are excluded at the investigators discretion
  • Therapeutic warfarin sodium or similar oral anticoagulants that are metabolized by the cytochrome p450 system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsEndometrial NeoplasmsUterine Cervical NeoplasmsFallopian Tube NeoplasmsBreast Neoplasms

Interventions

Docetaxelvatalanib

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 DisordersUterine NeoplasmsUterine DiseasesUterine Cervical DiseasesFallopian Tube DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Susana M. Campos, MD

    Dana-Farber Cancer Institute

    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
PRINCIPAL INVESTIGATOR
PI Title
Medical Oncologist

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 23, 2005

Study Start

September 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2011

Last Updated

July 27, 2018

Record last verified: 2018-07

Locations

US(2)