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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.

Sponsors and Collaborators: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005065
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: motexafin gadolinium
Drug: paclitaxel
Procedure: conventional surgery
Procedure: radiation therapy
Phase I

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Carboplatin    Paclitaxel    Motexafin gadolinium    Motexafin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   January 2000

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005065

Locations
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University    
      Columbus, Ohio, United States, 43210-1240

Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)

Investigators
Study Chair:     John C. Grecula, MD     Arthur G. James Cancer Hospital & Richard J. Solove Research Institute    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067669, OSU-0003, OSU-99H0355, OSU-T99-0073, NCI-T99-0073
First Received:   April 6, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00005065
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIIA non-small cell lung cancer  

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Carboplatin
Motexafin gadolinium
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Photosensitizing Agents
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Dermatologic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on December 03, 2008




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