Phase I, Pharmacokinetic, Pharmacodynamic Trial of PTK787 and Paclitaxel in Combination for Advanced Solid Tumors
This study has been completed.
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
First received: August 7, 2008
Last updated: September 10, 2014
Last verified: September 2014
This study will evaluate PTK787, a new oral drug that stops blood vessel development, in combination with Paclitaxel in patients with advanced solid tumors.
Drug: Paclitaxel plus PTK787
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase I, Pharmacokinetic, Pharmacodynamic Trial of PTK787 and Paclitaxel in Combination for Advanced Solid Tumors
Primary Outcome Measures:
- To evaluate the safety and tolerability of escalating doses of paclitaxel in combination with PTK787 [ Time Frame: Baseline through End of Study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the pharmacokinetics of paclitaxel alone and in combination with PTK787 from patients with cancer accrued to this study [ Time Frame: Baseline through End of Study ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2008 (Final data collection date for primary outcome measure)
Paclitaxel plus PTK787
Drug: Paclitaxel plus PTK787
Paclitaxel will be given on days 1 and 15 over 28 days in cycle 1 with PTK787 on days 3 to 28. PTK787 WILL BE TAKEN AT NIGHT.
In cycle 2 and beyond, paclitaxel will be given on days 1, 8 and 15 every 28 days . PTK787 will be taken orally NIGHTLY.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Adult patients with histologically confirmed malignancy that is unresponsive to curative therapy and for which no conventional therapy exists
- ECOG Performance Status 0-2
- Measurable or evaluable disease
- Laboratory values within protocol limits within 2 weeks prior to registration
- Life expectancy ≥ 12 weeks
- Patient or guardian must have written informed consent obtained according to local guidelines
- Women of child-bearing potential (non-sterile) must use appropriate barrier contraception for duration of study (negative pregnancy test required at baseline). Oral contraceptives will not be an acceptable form of contraception
- Patients may have received prior standard taxane therapy, but have never progressed on taxane-based therapy.
- History or presence of central nervous system (CNS) disease (i.e., primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis).
- Prior chemotherapy ≤ 3 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
- Prior biologic or immunotherapy ≤ 2 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
- Prior full pelvic field radiotherapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to randomization.
- Major surgery (i.e., laparotomy) ≤ 4 weeks prior to randomization. Minor surgery ≤ 2 weeks prior to randomization.
- Patients who have received investigational drugs ≤ 4 weeks prior to registration
- Prior therapy with anti-VEGF agents
- Peripheral neuropathy with functional impairment ≥ CTC grade 2 neuropathy, regardless of causality
- Pleural effusion or ascites that causes respiratory compromise (≥ CTC grade 2 dyspnea)
- Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control.
- Patient agrees to avoid grapefruit (juice and fruit)
Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
- Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
- Unstable angina pectoris
- Congestive heart failure greater than NYHA classification ≥ Grade 1 (can be controlled with medication)
- Myocardial infarction ≤ 6 months prior to registration and/or randomization
- Serious uncontrolled cardiac arrhythmia
- Uncontrolled diabetes at discretion of investigator
- Active or uncontrolled infection requiring intravenous antibiotics
- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- Patients at risk of QT prolongation such as patients with congenital long QT syndrome or with long QTc at baseline (i.e. QTc greater than 450 msec in males, and greater than 470 msec in females) will be excluded
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731861
|Indiana University Simon Cancer Center
|Indianapolis, Indiana, United States, 46202 |
Indiana University School of Medicine
||Gabriela Chiorean, MD
||Indiana University School of Medicine
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 7, 2008
||September 10, 2014
||United States: Food and Drug Administration
United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2016
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors