Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Gynecological Cancer Patients - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Massachusetts General Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00268918

Purpose

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	Intervention	Phase
Ovarian Cancer Endometrial Cancer Cervical Cancer Fallopian Tube Cancer Peritoneal Cancer Breast Cancer	Drug: Docetaxel Drug: PTK787	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Ovarian Cancer

Drug Information available for: Docetaxel Vatalanib Butanedioic acid, compd. with N-(4-chlorophenyl)-4-(4-pyridinylmethyl)-1-phthalazinamine (1:1)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study
Official Title:	A Phase I Trial of Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Recurrent or Refractory Gynecological Cancer Patients

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To estimate the preliminary efficacy of this combination in both metastatic breast cancer patients and refractory gynecological patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	September 2005
Estimated Study Completion Date:	January 2010
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Intervention Details:

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. Participant can continue receiving study drug as long as disease does not progress.

Lead In: Given orally on day 4 and day 14 After Lead In: Given orally once a day. Participants may continue receiving study drug as long as their disease does not worsen

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268918

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Massachusetts General Hospital

Investigators

Principal Investigator:

Susana M. Campos, MD

Dana-Farber Cancer Institute

More Information

Responsible Party:	Dana-Farber Cancer Institute ( Susana M. Campos, MD )
Study ID Numbers:	05-020
Study First Received:	December 21, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00268918
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

PTK787
Metastatic breast cancer
Refractory gynecological cancer

Study placed in the following topic categories:

Ovarian cancer
Ovarian Neoplasms
Skin Diseases
Gonadal Disorders
Genital Neoplasms, Female
Uterine Diseases
Breast Neoplasms
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Fallopian Tube Neoplasms
Recurrence

Vatalanib
Fallopian Tube Diseases
Docetaxel
Genital Diseases, Female
Endometrial Neoplasms
Uterine Neoplasms
Endocrinopathy
Endometrial cancer
Fallopian tube cancer
Breast Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 15, 2009