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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00268918
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : July 27, 2018
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Susana M. Campos, MD, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Endometrial Cancer Cervical Cancer Fallopian Tube Cancer Peritoneal Cancer Breast Cancer Drug: Docetaxel Drug: PTK787 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Recurrent or Refractory Gynecological Cancer Patients
Study Start Date : September 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2011

Arm Intervention/treatment
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
Participants may continue receiving study drug as long as their disease does not worsen
Other Name: Taxotere

Drug: PTK787
Participants may continue receiving study drug as long as their disease does not worsen
Other Name: Vatalanib

Primary Outcome Measures :
  1. To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To estimate the preliminary efficacy of this combination in both metastatic breast cancer patients and refractory gynecological patients. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00268918

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
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Principal Investigator: Susana M. Campos, MD Dana-Farber Cancer Institute

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Responsible Party: Susana M. Campos, MD, Medical Oncologist, Dana-Farber Cancer Institute Identifier: NCT00268918     History of Changes
Other Study ID Numbers: 05-020
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Keywords provided by Susana M. Campos, MD, Dana-Farber Cancer Institute:
Metastatic breast cancer
Refractory gynecological cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Endometrial Neoplasms
Fallopian Tube Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Uterine Diseases
Fallopian Tube Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors