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


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasm Metastasis, Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and tolerability of escalating doses of paclitaxel in combination with PTK787

Outcome Time Frame:

Baseline through End of Study

Safety Issue:

Yes

Principal Investigator

Gabriela Chiorean, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University

Authority:

United States: Food and Drug Administration

Study ID:

0412-21/ IUCRO-0101

NCT ID:

NCT00731861

Start Date:

May 2005

Completion Date:

August 2010

Related Keywords:

  • Neoplasm Metastasis
  • Carcinoma
  • Neoplasms
  • Carcinoma
  • Neoplasm Metastasis

Name

Location

Indiana University Simon Cancer CenterIndianapolis, Indiana  46202