Iressa/Docetaxel in Non-Small-Cell Lung Cancer
This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: October 24, 2002
Last updated: July 27, 2012
Last verified: July 2012
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.
Non-small Cell Lung Cancer
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Study of ZD1839 (Iressa), Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor, in Combination With Docetaxel in Patients With Recurrent or Metastatic Advanced Non-Small Cell Lung Cancer
Primary Outcome Measures:
- Patient Response Rate to Iressa/Docetaxel [ Time Frame: 4 weeks cycles ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2003 (Final data collection date for primary outcome measure)
Experimental: Iressa + Docetaxel
250 mg by mouth daily each day for 4 weeks.
30 mg/m2 by IV on day 1 weekly for the first 3 weeks of each 4 week course.
Other Name: Taxotere
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
- The patient has signs and symptoms of keratoconjunctivitis sicca or incompletely treated eye infection.
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00048087
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Edward S. Kim, MD, BS
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 24, 2002
||July 27, 2012
||United States: Food and Drug Administration
Keywords provided by M.D. Anderson Cancer Center:
Non-small cell lung cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 13, 2015
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Molecular Mechanisms of Pharmacological Action