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Phase I, Pharmacokinetic, Pharmacodynamic Trial of PTK787 and Paclitaxel in Combination for Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Indiana University School of Medicine
Novartis
Information provided by: Indiana University
ClinicalTrials.gov Identifier: NCT00731861
  Purpose

This study will evaluate PTK787, a new oral drug that stops blood vessel development, in combination with Paclitaxel in patients with advanced solid tumors.


Condition Intervention Phase
Neoplasm Metastasis
Carcinoma
Drug: Paclitaxel plus PTK787
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Paclitaxel 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, Open Label, Single Group Assignment, Safety Study
Official Title: Phase I, Pharmacokinetic, Pharmacodynamic Trial of PTK787 and Paclitaxel in Combination for Advanced Solid Tumors

Further study details as provided by Indiana University:

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 ]

Enrollment: 28
Study Start Date: May 2005
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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.


  Eligibility

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731861

Locations
United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Novartis
Investigators
Principal Investigator: Gabriela Chiorean, MD Indiana University
  More Information

Click "All Cancer Types- Phase I Trials"  This link exits the ClinicalTrials.gov site

Responsible Party: Indiana University Simon Cancer Center ( E. Gabriela Chiorean, MD )
Study ID Numbers: 0412-21/ IUCRO-0101
Study First Received: August 7, 2008
Last Updated: August 7, 2008
ClinicalTrials.gov Identifier: NCT00731861  
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Study placed in the following topic categories:
Paclitaxel
Neoplasm Metastasis
Vatalanib
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplastic Processes
Pathologic Processes
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009