Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Gynecological Cancer Patients
This study has been completed.
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Susana M. Campos, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00268918
First received: December 21, 2005
Last updated: November 30, 2012
Last verified: November 2012
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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Docetaxel
U.S. FDA Resources
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 ]
| Enrollment: | 24 |
| Study Start Date: | September 2005 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: 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. Participant can continue receiving study drug as long as disease does not progress.
Other Name: Taxotere
Drug: PTK787
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
- 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
No publications provided
| Responsible Party: | Susana M. Campos, MD, Medical Oncologist, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00268918 History of Changes |
| Other Study ID Numbers: | 05-020 |
| Study First Received: | December 21, 2005 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dana-Farber Cancer Institute:
|
PTK787 Metastatic breast cancer Refractory gynecological cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Endometrial Neoplasms Uterine Cervical Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Adenoma Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Diseases |
Genital Diseases, Female Uterine Cervical Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Docetaxel |
ClinicalTrials.gov processed this record on May 22, 2013