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Phase II Study of Taxotere® (Docetaxel) + ZD1839 (IRESSA®) in Previously Untreated Elderly Patients (≥70 Years Old) With Stage III-b (With Malignant Pleural Effusion [MPE+]) or Stage IV Non-Small Cell Lung Cancer (NSCLC)


Phase 2
70 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

Phase II Study of Taxotere® (Docetaxel) + ZD1839 (IRESSA®) in Previously Untreated Elderly Patients (≥70 Years Old) With Stage III-b (With Malignant Pleural Effusion [MPE+]) or Stage IV Non-Small Cell Lung Cancer (NSCLC)


This trial is designed to test the efficacy and tolerability of a standard chemotherapy
agent, Docetaxel, in combination with an oral agent, Iressa, in elderly patients with
advanced stage lung cancer. Current practices utilize two chemotherapeutic medications that
may result in increased toxicities and poor outcomes in the elderly population. Treatment
consists of an infusion of docetaxel every 21 days for four doses while taking Iressa every
day. A computed tomography (CT) scan will measure disease response after two cycles.
Response determines continuation of treatment. Lab work will be collected before every
treatment. Side effect information will also be collected at every visit. Once the infusion
phase of the study is completed, a maintenance phase of taking just the Iressa begins and
disease assessment occurs every two months. This period will last until disease progression
is demonstrated.


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).

- Patients with combined alkaline phosphatase, AST and/or ALT elevations will not be
allowed to enroll on protocol.

- Patients must have recovered from all acute toxicities from previous therapy,
excluding alopecia.

- In keeping with the policies of the institution, patients must sign an informed
consent form indicating that they are aware of the investigational nature of this
study

- Patients with stable brain metastases after completion of radiation will be allowed
to enroll in this trial.

- Patients treated with adjuvant therapy more than six months ago will be allowed to
enroll in this trial.

- Cognitively impaired patients will be allowed to enroll on the trial if the legal
guardian signs the consent form after a full informed consent process is completed.
Whenever feasible the cognitively impaired person will also give assent to
participation in the trial.

Exclusion Criteria:

- Patients previously treated with chemotherapy or ZD1839.

- Patients with known or clinical evidence of active central nervous system (CNS)
metastasis. Patients with stable, previously treated brain metastases will be
allowed.

- Male Patients with female sexual partners in the reproductive age group who refuse to
use effective methods of contraception will be excluded from the trial.

- Patients with concurrent serious infections (i.e., receiving an intravenous
antibiotic) are not eligible.

- Patients with an unstable or serious concurrent medical condition are excluded.
Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent
(within 3 months) myocardial infarction, uncontrolled major seizure disorder, grade 3
neuropathies, spinal cord compression, superior vena cava syndrome, or any
psychiatric disorder that prohibits obtaining informed consent.

- Patients receiving other non-approved or investigational therapy concurrently or
within 30 days of Day 1 of trial treatment.

- Patients with a history of other cancers except basal cell skin cancers, carcinoma of
the cervix in situ, or curatively-treated cancers with > 2 years non-recurrence prior
to entry in the trial. Patients with a history of other cancers must have
histological confirmation that current disease is compatible with diagnosis of NSCLC.

- Peripheral neuropathy >2. (Peripheral neuropathy must be < grade 1)

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Docetaxel, ZD 1839, Polysorbate 80, or other agents used in the study.

- Patients with combined alkaline phosphatase, AST and/or ALT elevations will be
excluded from this protocol.

- Patients previously treated with radiation therapy.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate (ORR)

Outcome Description:

Response Rate: Complete Response (CR) + Partial Response (PR). To determine the response rate for Elderly (> 70 years) previously untreated patients with Stage IIIb (With MPE) or IV non-small cell lung cancer (NSCLC) receiving Taxotere + ZD1839. Best clinical response to treatment with combination was determined using Response Evaluation Criteria in Solid Tumors (RECIST V1.0): * Complete Response (CR)- Disappearance of all target lesions; * Partial Response (PR)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; * Progressive Disease (PD)- At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; * Stable Disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Outcome Time Frame:

Duration of time on study, an average of 19 months

Safety Issue:

No

Principal Investigator

Alberto Chiappori, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

MCC-12905

NCT ID:

NCT00231465

Start Date:

July 2003

Completion Date:

August 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • elderly
  • malignant pleural effusion
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Pleural Effusion
  • Pleural Effusion, Malignant

Name

Location

H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612