Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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

PURPOSE: Phase I/II trial to study the effectiveness of temozolomide and vinorelbine in treating patients who have recurrent brain metastases.

Further Study Information

OBJECTIVES:

• Determine the maximum tolerated dose of vinorelbine when administered in combination with temozolomide in patients with recurrent brain metastases (phase I accrual completed).

• Determine the safety and feasibility of this treatment regimen in these patients.

• Determine the efficacy of this treatment regimen, in terms of objective radiographic response and overall and progression-free survival, in these patients.

OUTLINE: This is a dose-escalation study of vinorelbine.

Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8 and oral temozolomide once daily on days 1-7 and 15-21. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 20-35 patients will be treated at that dose level.

Patients are followed every 3-4 months.

PROJECTED ACCRUAL: A minimum of 3 patients will be accrued for the phase I portion of this study and 20-35 patients will be accrued for the phase II portion of this study within 2 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed solid tumor with metastases to the brain

• Evaluable disease in brain by MRI or CT scan

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 8 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)

• SGOT and SGPT no greater than 3 times ULN

• Alkaline phosphatase no greater than 2 times ULN

Renal:

• Creatinine less than 1.5 times ULN

• BUN less than 1.5 times ULN

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No AIDS-related illness

• No nonmalignant systemic disease

• No psychiatric condition that would preclude study

• No acute infection requiring IV antibiotics

• No frequent vomiting or medical condition that would preclude oral medication intake (i.e., partial bowel obstruction)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior biologic therapy or immunotherapy and recovered

Chemotherapy:

• At least 4 weeks since prior chemotherapy and recovered

• No prior temozolomide, dacarbazine, or vinorelbine

• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 4 weeks since prior external beam radiotherapy

• At least 8 weeks since prior stereotactic radiosurgery

• Concurrent focal radiotherapy for progressive bony disease allowed if brain metastases are stable or responding

Surgery:

• At least 2 weeks since prior brain biopsy, craniotomy, or other surgery

Other:

• Recovered from all prior therapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Memorial Sloan-Kettering Cancer Center

Lauren E. Abrey

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00026494
Information obtained from ClinicalTrials.gov on February 06, 2012

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