ClinicalTrials.gg
CompletedNCT00310154Updated May 30, 2017

Gefitinib, Docetaxel, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

A Phase 1 interventional study of docetaxel and gefitinib in Lung Cancer, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by Wake Forest University Health Sciences · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jul 2007, 19 years 3 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
18 Years to 120 Years
Sex
All
01

Study summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as 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. Giving gefitinib together with docetaxel and radiation therapy may kill more tumor cells.

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

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of docetaxel that can be safely delivered in combination with gefitinib and a definitive course of 3-D planned thoracic radiotherapy in patients with stage III non-small cell lung cancer.

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

  • Chemoradiotherapy: Patients receive concurrent chemoradiotherapy comprising docetaxel IV over 30 minutes on day 1 and thoracic radiotherapy once daily on days 1-5 in weeks 1-7 in the absence of disease progression or unacceptable toxicity.
  • Consolidation chemotherapy: Beginning 2 weeks after the completion of chemoradiotherapy, patients receive consolidation chemotherapy comprising docetaxel IV over 60 minutes on days 1 and 22.
  • Gefitinib therapy: Patients also receive oral gefitinib once daily beginning at the start of chemoradiotherapy and continuing for up to 1 year* in the absence of disease progression.

NOTE: *Patients continue to receive gefitinib during the 2-week rest period between chemoradiotherapy and consolidation chemotherapy.

Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Tumor tissue is tested to determine correlation between epidermal growth factor receptor presence and response to treatment.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 45 patients will be accrued in this study.

02

Conditions studied

  • Lung Cancer

Keywords

  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • adenosquamous cell lung cancer
  • bronchoalveolar cell lung cancer
  • large cell lung cancer
  • squamous cell lung cancer
  • adenocarcinoma of the lung
03

In context

Lung Neoplasms

7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's planned enrollment of 45 is below the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.

Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following:

    • Squamous cell carcinoma
    • Adenocarcinoma (including bronchoalveolar cell)
    • Large cell anaplastic carcinoma (including giant and clear cell carcinomas)
  • Stage IIIA/B disease

    • Unresectable disease
    • Tumors adjacent to a vertebral body allowed

      • No demonstrable bone invasion
      • All gross disease must be able to be encompassed in the radiation boost field in accordance with the homogeneity criteria
    • Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in the radiation boost field in accordance with the homogeneity criteria

      • No scalene, supraclavicular, or contralateral hilar node involvement
    • Pleural effusion allowed if it is transudate, cytologically negative, and non-bloody AND tumor can be encompassed within a reasonable field of radiotherapy

      • No exudative, bloody, or cytologically malignant effusions
      • Pleural effusion seen on chest CT scan but not on chest x-ray and too small to tap allowed
  • Measurable disease, defined as lesions that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan

    • No nonmeasurable disease, including any of the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
      • Tumor lesions situated in a previously irradiated area

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Granulocyte count ≥ 1,500/mm\^3
  • Hemoglobin > 8.0 g/dL
  • Platelet count ≥ 100,000/mm\^3
  • Bilirubin \< 1.5 mg/dL
  • Creatinine \< 1.5 times upper limit of normal (ULN)
  • Meets 1 of the following criteria:

    • AST and ALT \< 2 times ULN
    • AST and ALT ≤ 2.5 times ULN AND alkaline phosphatase (AP) normal
    • AST and ALT normal AND AP ≤ 4 times ULN
  • FEV_1 ≥ 1.2 L
  • No other currently active malignancy except nonmelanoma skin cancers

    • Patients are not considered to have another currently active malignancy if they have completed therapy for the other malignancy and are considered by their physician to be at \< 30% risk of relapse (i.e., after treatment for early-stage prostate cancer)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 3 months after completing treatment
  • No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No known severe hypersensitivity to gefitinib or any of the excipients of this product
  • No evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  • No evidence of any other significant clinical disorder or laboratory finding that would limit compliance with study requirements
  • No evidence of clinically active interstitial lung disease (asymptomatic, chronic stable radiographic changes allowed)
  • No peripheral neuropathy ≥ grade 1

PRIOR CONCURRENT THERAPY:

  • At least 2 weeks since prior formal exploratory thoracotomy
  • No prior chemotherapy or radiotherapy for NSCLC
  • No prior epidermal growth factor-targeting drugs (i.e., gefitinib, erlotinib, or cetuximab)
  • No other investigational agent within 30 days of study entry
  • No concurrent phenytoin, carbamazepine, rifampicin, barbiturates, or Hypericum perforatum (St John's wort)
  • No other concurrent hormonal therapy or chemotherapy except for the following:

    • Steroids for adrenal failure, allergic reactions, or septic shock
    • Hormones for nondisease-related conditions (e.g., insulin for diabetes)
    • Glucocorticosteroids as anti-emetics
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Interventions

06

What researchers measure

Primary outcomes

  1. To determine the feasability of daily ZD1839 delivered with concurrent 3-dimensional planned thoracic radiation

    Time frame: baseline to 2 months

07

Study locations

1 site
  • Wake Forest University Comprehensive Cancer Center
    Winston-Salem, North Carolina 27157-1082, United States
08

References and documents

Publications

  • Center B, Petty WJ, Ayala D, Hinson WH, Lovato J, Capellari J, Oaks T, Miller AA, Blackstock AW. A phase I study of gefitinib with concurrent dose-escalated weekly docetaxel and conformal three-dimensional thoracic radiation followed by consolidative docetaxel and maintenance gefitinib for patients with stage III non-small cell lung cancer. J Thorac Oncol. 2010 Jan;5(1):69-74. doi: 10.1097/JTO.0b013e3181c59a0e. PubMed 20035186 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2003, a primary completion of Jul 2007 and a completion of Aug 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2006
First posted
Apr 3, 2006
Start
Nov 2003
Primary completionActual
Jul 2007
CompletionActual
Aug 2010
Last update
May 30, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00310154
Responsible party
Sponsor
First posted
Apr 3, 2006
Start date
Nov 2003
Primary completion
Jul 2007
Completion
Aug 2010
Last update
May 30, 2017

Study contacts

Arthur William Blackstock, MD
study chair · Wake Forest University Health Sciences
Antonius A. Miller, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Docetaxel · Gefitinib

Start the discussion