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A Phase I Trial of Farnesyltransferase Inhibitor, R115777 (NSC # 702818) and Radiotherapy in Patients With Non-Small Cell Lung Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase I Trial of Farnesyltransferase Inhibitor, R115777 (NSC # 702818) and Radiotherapy in Patients With Non-Small Cell Lung Cancer


OBJECTIVES:

- Determine the maximum tolerated dose and dose-limiting toxicity of tipifarnib given
concurrently with radiotherapy after induction chemotherapy comprising paclitaxel and
carboplatin and followed by maintenance therapy with tipifarnib in patients with stage
IIIA or IIIB non-small cell lung cancer.

- Determine the tumor response at 3 months in patients treated with this regimen.

OUTLINE: This is multicenter, dose-escalation study of tipifarnib.

Patients receive induction chemotherapy comprising carboplatin IV over 30 minutes on day 1
and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 2
courses.

Beginning 4-6 weeks after the completion of induction chemotherapy, patients receive oral
tipifarnib twice daily for 7 weeks. Patients undergo radiotherapy once daily 5 days a week
for 7 weeks beginning 3 days after the start of tipifarnib. After completion of
radiotherapy, patients receive oral tipifarnib twice daily for 4 days and then once daily
for 4 days.

Cohorts of 3-6 patients receive escalating doses of tipifarnib while receiving radiotherapy
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting
toxicity.

Beginning 4-6 weeks after the completion of radiotherapy and tipifarnib, patients receive
maintenance therapy comprising oral tipifarnib twice daily on days 1-21. Maintenance therapy
repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3, 6, and 12 months.

PROJECTED ACCRUAL: Approximately 9-12 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed non-small cell lung cancer

- Locally advanced (stage IIIA or IIIB) disease requiring radiotherapy

- No malignant pleural effusion

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,500/mm^3

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

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- No grade 2 or greater elevation of liver function tests

Renal:

- Creatinine no greater than 1.5 times normal

Pulmonary:

- FEV_1 at least 600 cc

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No grade 3 or 4 peripheral neuropathy

- No known allergy to imidazole drugs (e.g., ketoconazole, miconazole, econazole, or
terconazole)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Up to 2 prior or concurrent carboplatin and paclitaxel chemotherapy regimens allowed

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- No prior thoracic radiotherapy

Surgery:

- At least 3 weeks since prior exploratory thoracotomy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Stephen Michael Hahn, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068965

NCT ID:

NCT00025480

Start Date:

August 2001

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283