CClinicalTrials.gg
Sign In
CompletedNCT00268918Updated Jul 27, 2018

Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Gynecological Cancer Patients

A Phase 1 interventional study of Docetaxel and PTK787 in Ovarian Cancer, Endometrial Cancer and Cervical Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-27.

Sponsored by Dana-Farber Cancer Institute · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description
  • Patients will come to the clinic once a week to receive study treatment. To help reduce the chance of an allergic reaction patients will take Decadron tablets orally the night before, the morning of and the evening of receiving chemotherapy.
  • The lead-in schedule of dosing is as follows: Day 1: Taxotere intravenously; Day 4: PTK787 orally; Day 14: Taxotere and PTK787.
  • After the lead-in schedule, a cycle will consist of 28 days. PTK787 will be given orally once a day without interruption. Taxotere will be given on Day 1, Day 8, Day 15 and Day 22.
  • Before each dose of Taxotere, blood tests, urine tests, and a physical exam will be done. A radiological evaluation will be done every two months. If the patients tumor remains stable or shrinks in size, they may continue to stay on the study.
  • Patients should not eat grapefruit or drink grapefruit juice during this study.
02

Conditions studied

  • Ovarian Cancer
  • Endometrial Cancer
  • Cervical Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • Breast Cancer

Keywords

  • PTK787
  • Metastatic breast cancer
  • Refractory gynecological cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 24 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 4 weeks or greater since major surgery, 3 weeks or greater since chemotherapy
  • Certain lab values
  • Negative for proteinuria

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Docetaxel / PTK787

    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: Docetaxel · Drug: PTK787

Interventions

  • DrugDocetaxel

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

    Also known as: Taxotere

  • DrugPTK787

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

    Also known as: Vatalanib

06

What researchers measure

Primary outcomes

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

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 2 years

07

Study locations

2 sites
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00268918
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital
Responsible party
Susana M. Campos, MD (Medical Oncologist, Dana-Farber Cancer Institute) — Principal investigator
First posted
Dec 23, 2005
Start date
Sep 2005
Primary completion
Jan 2007
Completion
Jan 2011
Last update
Jul 27, 2018

Study contacts

Susana M. Campos, MD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Breast Neoplasms→

Other studies from this sponsor

Dana-Farber Cancer Institute

Start the discussion