NCT00356941

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 .

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1 lung-cancer

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

1.1 years

First QC Date

July 26, 2006

Last Update Submit

November 27, 2017

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of oxaliplatin in combination with docetaxel and radiotherapy

    Within 90 days of radiotherapy

Secondary Outcomes (2)

  • Dose-limiting toxicities

    Within 90 days of radiotherapy

  • Objective tumor response

    Every 3 months up to 24 months

Study Arms (1)

Chemoradiation Treated Patients

EXPERIMENTAL

Patients receiving Docetaxel, Oxaliplatin and radiotherapy.

Drug: docetaxelDrug: oxaliplatinProcedure: radiation therapy

Interventions

docetaxelDRUG

60 mg/m2 on day 1 of each week during radiation therapy

Also known as: Taxotere
Chemoradiation Treated Patients
oxaliplatinDRUG

Escalating dose per assignment: 20-50 mg/m2 on day 2 of each week during radiation therapy

Also known as: Eloxatin
Chemoradiation Treated Patients
radiation therapyPROCEDURE

2 Gy Days 1-5 each week, total dose of 70Gy

Also known as: radiotherapy
Chemoradiation Treated Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +4 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

DocetaxelOxaliplatinRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesTherapeutics

Study Officials

  • L. Chinsoo Cho, MD

    Masonic Cancer Center, University of Minnesota

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2006

First Posted

July 27, 2006

Study Start

April 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations

US(1)