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Completed

NCT Number: NCT00268918

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

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.

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Key information

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

docetaxel

Drug

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

Other names: Taxotere

PTK787

Drug

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

Other names: Vatalanib

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

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Brigham and Women's Hospital
  • Massachusetts General Hospital

Registry information

Official study title

A Phase I Trial of Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Recurrent or Refractory Gynecological Cancer Patients

Important dates

Study start
2005
Primary completion
2007
Study completion
2011
First posted
Dec 23, 2005
Registry last updated
Jul 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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