Status:
TERMINATED
Trial of PTK787/ZK 222584 Plus Paclitaxel
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Novartis Pharmaceuticals
Beth Israel Deaconess Medical Center
Conditions:
Metastatic Non-hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
PTK787/ZK 222584 is an inhibitor of VEGFR family tyrosine kinases. The primary objective of this study is to assess the safety of daily oral PTK787/ZK 222584 in combination with paclitaxel infused eve...
Detailed Description
* We are looking for the highest dose of Paclitaxel that can be given safely in combination with the highest safe dose of Vatalanib. Therefore, not all people will receive the same dose of the study d...
Eligibility Criteria
Inclusion
- Patients with advanced solid tumors for whom there is no potentially curative treatment (surgery, radiation therapy or chemotherapy).
- Measurable or non-measurable disease
- Age ≥ 18 years old
- ECOG Performance Status 0 -1
- Laboratory values ≤ 14 days weeks prior to starting study treatment:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L (≥ 1500/mm3)
- Platelets (PLT) ≥ 100 x 109/L (≥ 100,000/mm3)
- Hemoglobin (Hgb) ≥ 9 g/dL
- Serum creatinine ≤ 1.5 ULN
- Serum bilirubin ≤ 1.0 x ULN
- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 x ULN (≤ CTC grade 1).
- Negative for proteinuria based on dip stick reading OR, if documentation of +1 result for protein on dip stick reading, then total urinary protein ≤ 500 mg and measured creatinine clearance (CrCl) ≥ 50 mL/min from a 24-hour urine collection
- Women of child-bearing age must have a negative serum or urine test.
- Life expectancy ≥ 12 weeks
- Written informed consent obtained
- Resolution of toxicity from previous chemotherapy to ≤ Grade I.
- QTc interval ≤ 0.45 seconds (men) or ≤ 0.47 seconds (women).
Exclusion
- Previous hypersensitivity reaction to taxanes or cremophor.
- History or presence of central nervous system (CNS) disease (i.e., primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis).
- Prior chemotherapy ≤ 4 weeks prior to registration. Prior nitrosoureas or mitomycin C ≤ 6 weeks prior to registration.
- Prior biologic or immunotherapy ≤ 2 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
- Prior radiotherapy ≤ 4 weeks prior to registration. Patients must have recovered from all therapy-related toxicities. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease
- Major surgery (i.e., laparotomy) ≤ 4 weeks prior to registration. Minor surgery ≤ 2 weeks prior to registration. Insertion of a vascular access device is not considered major or minor surgery in this regard. Patients must have recovered from all surgery-related toxicities
- Patients who have received investigational drugs ≤ 4 weeks prior to registration.
- 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 who are not employing an effective method of birth control. Barrier contraceptives must be used throughout the trial in both sexes. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Please refer to appendix for a list of examples of substrates of human liver microsomal P450 enzymes
- 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
- Symptomatic congestive heart failure
- Myocardial infarction ≤ 6 months prior to registration and/or randomization
- Serious uncontrolled cardiac arrhythmia
- Uncontrolled diabetes
- Active or uncontrolled infection
- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- Acute or chronic liver disease (eg., hepatitis, cirrhosis)
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK787/ZK 222584 (i.e., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction, or inability to swallow the tablets)
- Patients with confirmed diagnosis of human immunodeficiency virus (HIV) infection are excluded at the investigator's discretion if he/she feels that 1) a potential drug interaction between PTK787/ZK 222584, paclitaxel and any of the patient's anti-HIV medications could influence the efficacy of the anti-HIV medication, or 2) it may place the patient at risk due to the pharmacologic activity of PTK787/ZK 222584. Please refer to appendix for a list of examples of substrates of human liver microsomal P450 enzymes
- Patients who are taking therapeutic warfarin sodium (Coumadin) or similar oral anticoagulants that are metabolized by the cytochrome P450 system. Heparin products are allowed. Please refer to appendix for a list of examples of substrates of human liver microsomal P450 enzymes
- Patients unwilling to or unable to comply with the protocol
- Use of recombinant G-CSF products (Neupogen, Neulasta) within three weeks of registration. Chronic use of recombinant erythropoietin is permitted.
Key Trial Info
Start Date :
April 26 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2008
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00358163
Start Date
April 26 2006
End Date
May 29 2008
Last Update
April 29 2022
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115