Trial of PTK787/ZK 222584 Plus Paclitaxel

NCT00358163 | Terminated Phase 1

• 1 other identifier: 05-046
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

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 every 21 days. Secondary objectives include pharmacokinetic assessment of the impact of PTK787/ZK 222584 on paclitaxel metabolism and evaluation of tumor response to the investigational treatment.

Conditions

Metastatic Non-hematologic Malignancies

Keywords

angiogenesis; taxane; tyrosine kinase; pharmacokinetics; Vatalanib; Taxol

Outcome Measures

Primary Outcomes (1)

• Safety of PTK787/ZK 222584 in combination with paclitaxel

  2 years

Secondary Outcomes (1)

• Pharmacokinetic effect of PTK787/ZK 222584 on paclitaxel metabolism. Clinical tumor response to study treatment.

  2 years

Study Arms (1)

PTK787/ZK 222584

EXPERIMENTAL

Drug: PTK787/ZK 222584; Drug: paclitaxel

Interventions

PTK787/ZK 222584 DRUG

Taken in tablet form daily

Also known as: Vatalanib

PTK787/ZK 222584

paclitaxel DRUG

Given as a 3-hour infusion once every 21 days

PTK787/ZK 222584

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Novartis Pharmaceuticals: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

vatalanib; Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Pankaj Bhargava, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2006
• First Posted: July 31, 2006
• Study Start: April 26, 2006
• Primary Completion: May 29, 2008
• Study Completion: May 29, 2008
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

US (3)