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


Phase 1
18 Years
75 Years
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Daniel M. Sullivan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000068080

NCT ID:

NCT00006088

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612