Phase I, Pharmacokinetic, Pharmacodynamic Trial of PTK787 and Paclitaxel in Combination for Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00731861
First received: August 7, 2008
Last updated: September 10, 2014
Last verified: September 2014
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I, Pharmacokinetic, Pharmacodynamic Trial of PTK787 and Paclitaxel in Combination for Advanced Solid Tumors

Resource links provided by NLM:


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
Study Completion Date: August 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
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

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

No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00731861     History of Changes
Other Study ID Numbers: 0412-21/ IUCRO-0101
Study First Received: August 7, 2008
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014