Tipifarnib Plus Radiation Therapy After Combination Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

NCT00025480 | Completed Phase 1

• 3 other identifiers: CDR0000068965UPCC-NCI-5150NCI-5150
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Interventions

carboplatin DRUG

paclitaxel DRUG

tipifarnib DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Paclitaxel; tipifarnib; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics

Study Officials

• Stephen Michael Hahn, MD

  Abramson Cancer Center at Penn Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: August 1, 2001
• Last Updated: March 13, 2019

Record last verified: 2007-04

Locations

US (1)