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

Phase 1
18 Years
Not Enrolling
Ovarian Cancer, Endometrial Cancer, Cervical Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Breast Cancer

Thank you

Trial Information

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

- 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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Susana M. Campos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

January 2011

Related Keywords:

  • Ovarian Cancer
  • Endometrial Cancer
  • Cervical Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • Breast Cancer
  • PTK787
  • Metastatic breast cancer
  • Refractory gynecological cancer
  • Breast Neoplasms
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Adenoma



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617