Phase II Study of Docetaxel + ZD1839 in Elderly Patients With Non-Small Cell Lung Cancer (NCT00231465) | Clinical Trial Compass
CompletedPhase 2
Phase II Study of Docetaxel + ZD1839 in Elderly Patients With Non-Small Cell Lung Cancer
United States44 participantsStarted 2003-07
Plain-language summary
This is a Phase II, open-label trial of Taxotere® + ZD1839 in elderly patients with Stage III-b or IV NSCLC who have received no prior chemotherapy for metastatic disease. Patients with prior adjuvant chemotherapy were allowed to enroll on this trial.
Who can participate
Age range70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must be greater than or equal to 70 years of age.
* Patients must have histologically confirmed non-small cell lung cancer (NSCLC) that is Stage IIIb (with pleural effusions) or Stage IV.
* Patients must be previously untreated for metastatic disease but may have received previous adjuvant chemotherapy more than six months prior to registration. Patients may also have received radiation therapy for advanced disease; however there should be measurable disease outside the radiation ports.
* Disease must be at least unidimensionally measurable. Lesions, which are located within a previously irradiated field, are not considered measurable unless there is a documented growth in its size.
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Laboratory values must be as follows: White blood cell count greater than or equal to 3,000/mm\^3; Absolute neutrophil count greater than or equal to 1,500/mm\^3; Platelets greater than or equal to 100,000/mm\^3; Total bilirubin less than or equal to 1.0 x institutional upper normal limit; Serum creatinine less than or equal to 2 x institutional upper normal limit; aspartic transaminase (AST) or ALANINE TRANSAMINASE (ALT) less than or equal to 1.5 x institutional upper normal limit; Alkaline Phosphatase less than or equal to 1.5 x institutional upper normal limit; Serum calcium less than or equal to 1.5 x institutional upper normal limit (corrected for serum albumin).
*…
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: Duration of time on study, an average of 19 months
Trial details
NCT IDNCT00231465
SponsorH. Lee Moffitt Cancer Center and Research Institute