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Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
This study has been completed.
Study NCT00005065   Information provided by National Cancer Institute (NCI)
First Received: April 6, 2000   Last Updated: February 6, 2009   History of Changes

April 6, 2000
February 6, 2009
January 2000
 
 
 
Complete list of historical versions of study NCT00005065 on ClinicalTrials.gov Archive Site
 
 
 
Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
A Phase I Study of Induction Carboplatin/Paclitaxel Chemotherapy, Pre-Operative Radiotherapy With Gadolinium Texaphyrin (Gd-Tex), and Surgical Resection in Stage IIIA (N2) Non-Small Cell Lung Carcinoma

RATIONALE: 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.

PURPOSE: 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.

OBJECTIVES:

  • 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.
  • 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.

PROJECTED ACCRUAL: A total of 3-12 patients will be accrued for this study within 1 year.

Phase I
Interventional
Treatment
Lung Cancer
  • Drug: carboplatin
  • Drug: motexafin gadolinium
  • Drug: paclitaxel
  • Procedure: conventional surgery
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

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

    • T1-T3, N2, M0
    • Must appear resectable

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin normal
  • AST no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 2 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Pulmonary:

  • FEV greater than 0.8 L

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior chest radiotherapy in area of tumor/nodes

Surgery:

  • Not specified

Other:

  • No other concurrent investigational agents
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005065
 
CDR0000067669, OSU-0003, OSU-99H0355, OSU-T99-0073, NCI-T99-0073
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Study Chair: John C. Grecula, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
June 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP