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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


Phase 2
N/A
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

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


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Response Rate to Iressa/Docetaxel

Outcome Time Frame:

4 weeks cycles

Safety Issue:

No

Principal Investigator

Edward S. Kim, MD, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID02-004

NCT ID:

NCT00048087

Start Date:

August 2002

Completion Date:

July 2003

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030