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Phase I Study of Oxaliplatin in Combination With Docetaxel and Radiotherapy in Patients With Unresectable or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Phase 1
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase I Study of Oxaliplatin in Combination With Docetaxel and Radiotherapy in Patients With Unresectable or Recurrent Non-Small Cell Lung Cancer (NSCLC)



- 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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of oxaliplatin in combination with docetaxel and radiotherapy

Outcome Time Frame:

Within 90 days of radiotherapy

Safety Issue:


Principal Investigator

L. Chinsoo Cho, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Minnesota - Clinical and Translational Science Institute


United States: Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

May 2007

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Minnesota Cancer Center Minneapolis, Minnesota  55455