Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer

NCT ID: NCT00005065

Last Updated: 2013-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-31

Brief Summary

Phase I trial to study the effectiveness of combining carboplatin and paclitaxel, radiation therapy with gadolinium texaphyrin, and surgery in treating patients who have stage IIIA non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy. Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells.

Detailed Description

OBJECTIVES:

I. Determine and compare the frequency and grade of toxicities with the use of gadolinium texaphyrin as a radiosensitizer at two dose levels during preoperative radiotherapy in patients with stage IIIA non-small cell lung cancer.

II. Measure the tumor, involved lymph nodes, and normal lung concentrations of gadolinium and compare to the image pixel intensity obtained by the 1.5 Tesla MRI in this patient population given this regimen.

OUTLINE: This is a dose escalation study of gadolinium texaphyrin (Gd-Tex).

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours every 3 weeks for 3 courses. Three weeks after completion of induction chemotherapy, patients receive Gd-Tex IV over 30 minutes twice weekly for 10 doses during preoperative radiotherapy. Radiotherapy is administered daily 5 days a week for 5 weeks. Approximately 3.5 weeks after completion of preoperative radiotherapy, patients undergo complete surgical resection. Three hours prior to surgery, patients receive an eleventh dose of Gd-Tex if they do not develop grade 3 or 4 toxicity with the tenth dose. Patients also receive a MRI without contrast prior to surgery. If the tumor is found to be unresectable, patients may receive additional radiation and/or chemotherapy.

Cohorts of 3-6 patients receive escalating doses of Gd-Tex until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities.

Patients are followed at 1 month and then every 4 months for 5 years.

Conditions

Stage IIIA Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours every 3 weeks for 3 courses. Three weeks after completion of induction chemotherapy, patients receive Gd-Tex IV over 30 minutes twice weekly for 10 doses during preoperative radiotherapy. Radiotherapy is administered daily 5 days a week for 5 weeks. Approximately 3.5 weeks after completion of preoperative radiotherapy, patients undergo complete surgical resection. Three hours prior to surgery, patients receive an eleventh dose of Gd-Tex if they do not develop grade 3 or 4 toxicity with the tenth dose. Patients also receive a MRI without contrast prior to surgery. If the tumor is found to be unresectable, patients may receive additional radiation and/or chemotherapy.

Group Type: EXPERIMENTAL

paclitaxel

Intervention Type: DRUG

Given IV

carboplatin

Intervention Type: DRUG

Given IV

motexafin gadolinium

Intervention Type: DRUG

Given IV

conventional surgery

Intervention Type: PROCEDURE

Undergo complete surgical resection

radiation therapy

Intervention Type: RADIATION

Undergo radiation therapy

Interventions

paclitaxel

Given IV

Intervention Type: DRUG

carboplatin

Given IV

Intervention Type: DRUG

motexafin gadolinium

Given IV

Intervention Type: DRUG

conventional surgery

Undergo complete surgical resection

Intervention Type: PROCEDURE

radiation therapy

Undergo radiation therapy

Intervention Type: RADIATION

Other Intervention Names

Anzatax; Asotax; TAX; Taxol; Carboplat; CBDCA; JM-8; Paraplat; Paraplatin; gadolinium texaphyrin; Gd (III) Texaphryin; Gd-Tex; PCI-0120; Xcytrin; surgery, conventional; irradiation; radiotherapy; therapy, radiation

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed non-small cell carcinoma of the lung
• Surgical staging with mediastinoscopy or anterior thoracotomy required

• T1-T3, N2, M0
• Must appear resectable
• Performance status - Karnofsky 70-100%
• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Bilirubin normal
• AST no greater than 2.5 times upper limit of normal
• Creatinine no greater than 2 mg/dL
• Creatinine clearance at least 60 mL/min
• No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
• FEV greater than 0.8 L
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Weight loss no greater than 10% of total body weight within past 3 months
• No evidence of neuropathy
• No history of allergy to platinum compounds, paclitaxel, porphyrins, or antiemetics appropriate for administration in conjunction with protocol chemotherapy
• No concurrent uncontrolled illness (e.g., active infection)
• No medical contraindication to MRI (e.g., pacemaker or aneurysm clip)
• No G6PD deficiency
• No known history of porphyria
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
• No prior chest radiotherapy in area of tumor/nodes
• No other concurrent investigational agents

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Grecula

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

OSU 0003

Identifier Type: -

Identifier Source: secondary_id

OSU-0003

Identifier Type: -

Identifier Source: secondary_id

NCI-T99-0073

Identifier Type: -

Identifier Source: secondary_id

OSU-99H0355

Identifier Type: -

Identifier Source: secondary_id

OSU-T99-0073

Identifier Type: -

Identifier Source: secondary_id

CDR0000067669

Identifier Type: -

Identifier Source: secondary_id

U01CA076576

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-01401

Identifier Type: -

Identifier Source: org_study_id