Clinical trial NCT00268918: Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Gynecological Cancer Patients
Official title: A Phase I Trial of Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Recurrent or Refractory Gynecological Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ovarian Cancer
Endometrial Cancer
Cervical Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Breast Cancer
Keywords: PTK787
Metastatic breast cancer
Refractory gynecological cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Massachusetts General Hospital
First posted: 2005-12-23
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787.
timeFrame: 2 years
Secondary outcomes:
measure: To estimate the preliminary efficacy of this combination in both metastatic breast cancer patients and refractory gynecological patients.
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Susana M. Campos, MD
role: PRINCIPAL_INVESTIGATOR
References: