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Iressa/Docetaxel in Non-Small-Cell Lung Cancer | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Iressa/Docetaxel in Non-Small-Cell Lung Cancer

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

NCT00048087•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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.

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.
+6 more criteria

Locations (1)

UT MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

August 1, 2002

Primary Completion Date

July 1, 2003

Completion Date

July 1, 2003

Last Updated

July 31, 2012

Conditions

Non-small Cell Lung Cancer

Interventions

ZD1839

DRUG

Docetaxel

DRUG

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Iressa/Docetaxel in Non-Small-Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)