Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC

April 21, 2015 updated by: Heather Wakelee, Stanford University

A Phase II Trial of Concurrent Docetaxel (Taxotere) / Carboplatin / Radiotherapy Followed by Surgical Resection Followed by Consolidation Taxotere / Carboplatin in Stage III Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to assess how well this particular combination of chemotherapy, radiation and surgery works to help people with locally advanced lung cancer, how well PET scans indicates whether someone has responded to chemotherapy and radiation, and gene expression patterns related to outcomes in patients with locally advanced lung cancer who receive this treatment regimen.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Histologically confirmed stage IIIA or IIIB NSCLC

  • Patients must have measurable disease
  • No previous chemotherapy, radiation therapy or other systemic therapy for their NSCLC.
  • Age>18 years
  • Life expectancy >12 months
  • ECOG performance status 0-1
  • Normal organ and marrow function
  • Medically fit for surgery at time of enrollment.
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study. Women must have a negative pregnancy test prior to enrollment.
  • Ability to understand and willingness to sign the consent form.

Exclusion Criteria:

  • Previous chemotherapy, radiation therapy or any other systemic treatment for their NSCLC.
  • Patients receiving any other investigational agents.
  • Known metastatic disease (brain or any other site)
  • History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 or with allergic reactions to compounds of similar chemical composition to carboplatin or other agents used in the study.
  • Peripheral neuropathy >grade 1
  • Uncontrolled concurrent illness
  • Pregnant women
  • Weight loss>10% in the past 3 months before diagnosis.
  • Hyperglycemia - exclusion from PET analysis
  • HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with docetaxel and carboplatin or other agents administered during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Chemotherapy+Radiation+Surgery
  1. Concurrent weekly docetaxel at 20 mg/m2 and weekly carboplatin at an AUC of 2 with thoracic radiotherapy of 180-200cGy/day for 5/7 days to 45 Gy.
  2. Complete surgical excision 3-6 weeks after completion of chemoradiotherapy.
  3. No Surgery if patient is deemed unable to tolerate surgery, with completion to 61 Gy radiation
  4. Consolidation after surgery: Docetaxel given at 75 mg/m2 every 3 weeks with carboplatin at AUC 6 every 3 weeks with concomitant growth factor support.
Drug: Docetaxel
20 mg/m2, 75 mg/m2 infusion
Other Names:
  • Taxotere
Drug: Carboplatin
AUC of 2 and 6 infusion
Other Names:
  • Paraplatin
Procedure: Radiation therapy
NEOADJUVANT RADIOTHERAPY Radiation therapy will be concurrent with the chemotherapy. Radiation therapy will begin within 24 hours of chemotherapy. CONSOLIDATION RADIOTHERAPY Patients with positive surgical margins or incomplete resection (tumor shaved from spine or great vessels) will receive an additional boost of radiotherapy 3 to 6 weeks after surgery. This will be a 16 Gy boost given with concurrent weekly chemotherapy as during the neoadjuvant period.
Other Names:
  • radiotherapy
  • radiation oncology
Procedure: Surgical resection
All patients will be taken to surgical excision, unless they have developed a condition other than progressive disease, which would make surgery unsafe.
Other Names:
  • segmentectomy
  • segmental resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy.
Time Frame: Two years
Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse.
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival
Time Frame: baseline, 5 weeks after combined chemo-radiation
The change in standardized uptake values (SUV)max on PET scans obtained pre- and after 5 weeks of combined chemo-radiation for patients enrolled on the trial were evaluated for ability to predict outcomes including complete resection at time of surgery (3-6 weeks after completion of the chemo-radiation), progression-free survival and 2 year overall survival. The mean SUVmax pre chemoradiation minus the mean SUVmax post-radiation is reported.
baseline, 5 weeks after combined chemo-radiation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Analysis of Relation of Gene Expression Patterns to Outcomes in Patients With Locally Advanced Lung Cancer Who Receive This Treatment Regimen
Time Frame: Specimen collected at time of surgery
This analysis of gene expression patterns related to outcomes in patients with locally advanced lung cancer who received this treatment regimen was not performed due to lack of funding.
Specimen collected at time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Aventis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

October 11, 2005

First Submitted That Met QC Criteria

October 11, 2005

First Posted (ESTIMATE)

October 13, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUN0002
  • 11804 (OTHER: Stanford IRB)
  • 78999 (OTHER: Stanford University Alternate IRB Approval Number)
  • GIA #12169 (OTHER: Aventis)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carcinoma, Non-Small-Cell Lung

Clinical Trials on Docetaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe