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

University of Minnesota (UMN)

Status and phase

Terminated

Phase 1

Conditions

Lung Cancer

Treatments

Procedure: radiation therapy

Drug: docetaxel

Drug: oxaliplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00356941

2005LS073

UMN-OX-04-007 (Other Identifier)

UMN-0511M77529 (Other Identifier)

Details and patient eligibility

About

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 .

Full description

OBJECTIVES:

Primary

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.

Secondary

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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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