Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2002-08-31
2003-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Iressa + Docetaxel
ZD1839
250 mg by mouth daily each day for 4 weeks.
Docetaxel
30 mg/m2 by IV on day 1 weekly for the first 3 weeks of each 4 week course.
Interventions
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ZD1839
250 mg by mouth daily each day for 4 weeks.
Docetaxel
30 mg/m2 by IV on day 1 weekly for the first 3 weeks of each 4 week course.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Aventis Pharmaceuticals
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Edward S. Kim, MD, BS
Role: PRINCIPAL_INVESTIGATOR
UT MD Anderson Cancer Center
Locations
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UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center website
Other Identifiers
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ID02-004
Identifier Type: -
Identifier Source: org_study_id