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

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 1

Conditions: Endometrial Cancer; Breast Cancer; Peritoneal Cancer; Fallopian Tube Cancer; Ovarian Cancer; Cervical Cancer

Treatments: Drug: Docetaxel; Drug: PTK787

Study type: Interventional

Funder types: Other

Identifiers

NCT00268918

05-020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Docetaxel / PTK787

Experimental group

Description:

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.

Treatment:

Drug: PTK787

Drug: Docetaxel