Oxaliplatin, Docetaxel, and Radiation Therapy in Treating Patients With Unresectable Stage II/III or Recurrent NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00356941
Recruitment Status : Terminated (Withdrawn due to lack of accrual)
First Posted : July 27, 2006
Last Update Posted : November 29, 2017
Information provided by:
Masonic Cancer Center, University of Minnesota

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Oxaliplatin and docetaxel may make tumor cells more sensitive to radiation therapy. Giving oxaliplatin and docetaxel together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of oxaliplatin when given together with docetaxel and radiation therapy in treating patients with unresectable stage II or stage III or recurrent non-small cell lung cancer .

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: docetaxel Drug: oxaliplatin Procedure: radiation therapy Phase 1

Detailed Description:



  • Determine the maximum tolerated dose of oxaliplatin when given with docetaxel and thoracic radiotherapy in patients with unresectable stage II, IIIA, or IIIB or recurrent non-small cell lung cancer.


  • Determine the dose-limiting toxicities of this regimen in these patients.
  • Determine the objective tumor response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of oxaliplatin.

  • Induction therapy: Patients undergo radiotherapy once a day on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Patients also receive docetaxel intravenous (IV) over 1 hour on days 1, 8, 15, 22, 29, 36, and 43 and oxaliplatin IV over 2-4 hours on days 2, 9, 16, 23, 30, 37, and 44. Patients with stable or responding disease proceed to consolidation therapy.

Cohorts of 6 patients receive escalating doses of oxaliplatin during induction therapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity.

  • Consolidation therapy: Beginning 3 weeks after the completion of induction therapy, patients receive consolidation therapy comprising docetaxel IV over 1 hour immediately followed by oxaliplatin IV over 2-4 hours on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months for up to 2 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Oxaliplatin in Combination With Docetaxel and Radiotherapy in Patients With Unresectable or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Study Start Date : April 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Chemoradiation Treated Patients
Patients receiving Docetaxel, Oxaliplatin and radiotherapy.
Drug: docetaxel
60 mg/m2 on day 1 of each week during radiation therapy
Other Name: Taxotere
Drug: oxaliplatin
Escalating dose per assignment: 20-50 mg/m2 on day 2 of each week during radiation therapy
Other Name: Eloxatin
Procedure: radiation therapy
2 Gy Days 1-5 each week, total dose of 70Gy
Other Name: radiotherapy

Primary Outcome Measures :
  1. Maximum tolerated dose of oxaliplatin in combination with docetaxel and radiotherapy [ Time Frame: Within 90 days of radiotherapy ]

Secondary Outcome Measures :
  1. Dose-limiting toxicities [ Time Frame: Within 90 days of radiotherapy ]
  2. Objective tumor response [ Time Frame: Every 3 months up to 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

    • Medically inoperable or unresectable stage II, IIIA, or IIIB disease
    • Post-resection intrathoracic tumor recurrence
  • Measurable disease by computed tomography(CT) scan
  • No evidence of small cell histology
  • No significant pleural effusion on chest x-ray or malignant pleural effusion on cytology
  • No metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
  • Absolute granulocyte count ≥ 2,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 8.0 g/dL
  • Bilirubin ≤ 1.5 mg/dL
  • Serum glutamic oxaloacetic transaminase (SGOT) ≤ 1.5 times upper limit of normal (unless abnormality is caused by documented benign disease)
  • Creatinine ≤ 1.5 mg/dL
  • Weight loss ≤ 10% within the past 3 months
  • Forced expiratory volume (FEV) 1 ≥ 1,000 cc
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment

Exclusion Criteria:

  • Synchronous (except for nonmelanomatous skin cancer) or prior invasive malignancy, unless disease free for > 3 years
  • Myocardial infarction within the past 6 months
  • Symptomatic heart disease, including any of the following:

    • Angina
    • Congestive heart failure
    • Uncontrolled arrhythmia
  • Active infection or fever ≥ 38.5°C within the past 3 days
  • Known hypersensitivity to any of the components of oxaliplatin or docetaxel
  • Prior thoracic or neck radiotherapy
  • Prior docetaxel or oxaliplatin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00356941

United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Study Chair: L. Chinsoo Cho, MD Masonic Cancer Center, University of Minnesota

Responsible Party: Chinsoo Cho MD, Masonic Cancer Center, University of Minnesota Identifier: NCT00356941     History of Changes
Other Study ID Numbers: 2005LS073
UMN-0511M77529 ( Other Identifier: IRB, University of Minnesota )
UMN-OX-04-007 ( Other Identifier: Sanofi Research Division )
First Posted: July 27, 2006    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

Keywords provided by Masonic Cancer Center, University of Minnesota:
recurrent non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action