NCT00048087

Brief Summary

Patients will receive 250 mg Iressa by mouth daily each day while on this study. Patients will also receive docetaxel 30 mg/m2 by by vein (IV) on day 1 weekly for the first 3 weeks of each course of therapy. A course of therapy is 4 weeks. Patients will not receive docetaxel during week 4. A maximum of 8 full cycles of docetaxel plus Iressa are planned. Patients may continue on daily Iressa until progressive disease and/or unacceptable toxicity.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2002

Shorter than P25 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

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

August 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2002

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

Enrollment Period

11 months

First QC Date

October 24, 2002

Last Update Submit

July 27, 2012

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Patient Response Rate to Iressa/Docetaxel

    4 weeks cycles

Study Arms (1)

Iressa + Docetaxel

EXPERIMENTAL
Drug: ZD1839Drug: Docetaxel

Interventions

ZD1839DRUG

250 mg by mouth daily each day for 4 weeks.

Also known as: Iressa, Gefitinib
Iressa + Docetaxel
DocetaxelDRUG

30 mg/m2 by IV on day 1 weekly for the first 3 weeks of each 4 week course.

Also known as: Taxotere
Iressa + Docetaxel

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed non-small cell lung cancer.
  • Measurable, evaluable disease outside of a radiation port.
  • ECOG performance status 0-2.
  • Adequate hematologic function as defined by an absolute neutrophil count \>= 1,500/mm3, a platelet count \>= 100,000/mm3, a WBC \>= 3,000/ mm3, and a hemoglobin level of \>= 9 g/dl.
  • One prior chemotherapy regimen. This may include chemoradiation treatment.
  • Disease progression or recurrence within 6 months of last dose of chemotherapy in first chemotherapy regimen.
  • At least a 2-week recovery from prior therapy toxicity.
  • Signed informed consent.
  • Prior CNS involvement by tumor are eligible if previously treated and clinically stable for two weeks after completion of treatment.

You may not qualify if:

  • Prior Iressa or other EGFR inhibiting agents
  • Prior docetaxel therapy
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
  • Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
  • Incomplete healing from previous oncologic or other major surgery.
  • Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, St John's Wort, anti-coagulants.
  • Absolute neutrophil counts less than 1500 x 109/liter (L) or platelets less than 100,000x 109/liter (L).
  • Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).
  • In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease, (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
  • A serum creatinine \>= 1.5 mg/dl and calculated creatinine clearance \<= 60 cc/minute.
  • Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases or greater than 5 times the ULRR in the presence of liver metastases.
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial.
  • Pregnancy or breast feeding
  • The patient has uncontrolled seizure disorder, active neurological disease, or Grade \>= 2 neuropathy
  • The patient has received any investigational agent(s) within 30 days of study entry.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

GefitinibDocetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Edward S. Kim, MD, BS

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2002

First Posted

October 25, 2002

Study Start

August 1, 2002

Primary Completion

July 1, 2003

Study Completion

July 1, 2003

Last Updated

July 31, 2012

Record last verified: 2012-07

Locations

US(1)