Vinorelbine in Treating Patients With Metastatic or Advanced Solid Tumors

September 19, 2013 updated by: H. Lee Moffitt Cancer Center and Research Institute

A Phase I Absolute Bioavailability Study of Oral NAVELBINE (Vinorelbine Tartrate) in Patients With Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase I trial to compare the effectiveness of two different regimens of vinorelbine in treating patients who have metastatic or advanced solid tumors.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Compare the pharmacokinetic profiles of vinorelbine administered intravenously on day 1 and orally on day 8 vs the reverse order in patients with metastatic or advanced solid tumors. II. Determine the intersubject variability in the pharmacokinetics of oral vinorelbine. III. Compare the safety profiles of oral vs intravenous vinorelbine in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive vinorelbine IV over 20 minutes on day 1 and oral vinorelbine on day 8. Arm II: Patients receive oral vinorelbine on day 1 and vinorelbine IV over 20 minutes on day 8. Treatment continues in both arms in the absence of unacceptable toxicity or disease progression. Patients are followed for 28 days.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically confirmed metastatic or advanced solid tumor that will potentially benefit from single agent vinorelbine No known CNS metastases unless successfully treated with excision or radiotherapy and stable for at least 6 months prior to study

PATIENT CHARACTERISTICS: Age: 18-75 Performance status: Not specified Life expectancy: Greater than 3 months Hematopoietic: Hemoglobin at least 9 g/dL (at least 3 weeks since last transfusion) Platelet count at least 75,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Transaminases no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN No unstable or uncontrolled hypercalcemia Cardiovascular: No venous access problems that would preclude blood sampling No symptomatic class II-IV congestive heart failure No significant ventricular arrhythmia requiring drug control No myocardial infarction within the past 6 months No uncontrolled cardiac disease or unstable angina No recurrent thromboembolic events No unstable or uncontrolled arterial hypertension Pulmonary: No history of recurrent aspiration pneumonitis or aspiration pneumonia No severe respiratory insufficiency, defined by oxygen partial pressure less than 60 mm Hg on room air and requirement for chronic oxygen therapy Gastrointestinal: See Surgery No active gastrointestinal disease or disorder that alters gastrointestinal motility or absorption No lack of integrity of the gastrointestinal tract No unstable or uncontrolled diarrhea or peptic ulcer disease Other: Able to receive IV and oral regimens Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for at least 2 weeks before, during, and for at least 9 days after study No preexisting peripheral neuropathy greater than grade 1 No active infection within the past 2 weeks No fever (temperature at least 37.5 degrees C) or other symptoms of possible infection within 10 days after completing antimicrobial treatment No psychological, familial, or sociological condition that would preclude study No unstable or uncontrolled preexisting medical condition (e.g., diabetes, alcohol withdrawal)

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior packed red blood cell transfusion At least 1 week since prior platelet transfusion or hematopoietic growth factors No concurrent growth factors earlier than 24 hours after study drug Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered No other concurrent antineoplastic agents Endocrine therapy: At least 3 weeks since prior hormonal therapy and recovered Concurrent megestrol allowed No other concurrent hormonal therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Prior or concurrent palliative radiotherapy to peripheral bone lesion, spinal cord compression, or imminent fracture allowed only if less than 10% of bone marrow involved Surgery: No prior significant surgical resection of the stomach or small bowel At least 2 weeks since prior surgery Other: No other concurrent experimental or anticancer drugs or devices At least 1 week since prior products or drugs known to induce or inhibit the enzymatic activity of vinorelbine (e.g., antihistamines, phenobarbital, meprobamate, some antiepileptics, or grapefruit juice) No concurrent products or drugs known to induce or inhibit the enzymatic activity of vinorelbine No concurrent opiates or laxatives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Daniel M. Sullivan, MD, H. Lee Moffitt Cancer Center and Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Registration Dates

First Submitted

August 3, 2000

First Submitted That Met QC Criteria

June 21, 2004

First Posted (Estimate)

June 22, 2004

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

November 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068080
  • MCC-11982
  • GW-VIN10003
  • NCI-G00-1826

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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