Tipifarnib Plus Radiation Therapy After Combination Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 3/15/2019 |
| Start Date: | August 2001 |
A Phase I Trial of Farnesyltransferase Inhibitor, R115777 (NSC # 702818) and Radiotherapy in Patients With Non-Small Cell Lung Cancer
RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by making tumor cells more sensitive to radiation therapy.
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,
such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells
either by killing the cells or by stopping them from dividing and may also make tumor cells
more sensitive to radiation therapy.
PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when
given together with radiation therapy after combination chemotherapy in treating patients
with stage III non-small cell lung cancer.
needed for cell growth and by making tumor cells more sensitive to radiation therapy.
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,
such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells
either by killing the cells or by stopping them from dividing and may also make tumor cells
more sensitive to radiation therapy.
PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when
given together with radiation therapy after combination chemotherapy in treating patients
with stage III 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.
- 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.
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
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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