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Phase II Trial Of TAXOTERE + TARCEVA™ To Treat HRPC In Men ≥ 65 Years Of Age

Phase 2
65 Years
Not Enrolling
Prostate Cancer

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Trial Information

Phase II Trial Of TAXOTERE + TARCEVA™ To Treat HRPC In Men ≥ 65 Years Of Age



- Determine the response rate and response duration in older patients with progressive
hormone refractory prostate cancer treated with docetaxel and erlotinib.


- Determine the safety of this regimen in these patients.

- Evaluate the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

- Initial combination therapy: Patients receive docetaxel IV over 1 hour on day 1 and
oral erlotinib once daily on days 1-21. Treatment repeats every 21 days for up to 9
courses in the absence of disease progression or unacceptable toxicity. Patients with
responding disease receive 3 additional courses beyond maximal response.

- Extension phase: After 9 courses of initial combination therapy, patients achieving a
complete response, partial response, or stable disease receive 8 courses of erlotinib
alone (total of 17 courses of study treatment).

Quality of life is assessed at baseline, day 1 of each course, and at the end of study
treatment. For patients in the extension phase, quality of life is also assessed on day 1 of
courses 10, 12, 14, and 16.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study within 24 months.

Inclusion Criteria

Inclusion Criteria

- Histologically confirmed adenocarcinoma of the prostate.

- Disease progression following primary or secondary hormonal therapy.

- All patients must be maintained on GnRH analog during this study.

- Serum PSA must be > 20 ng/mL in patients without bidimensionally measurable disease
or bone disease.

- Age > 65 years.

- Karnofsky performance status of > 70%.

- Life Expectancy of > 12 weeks.

- Peripheral neuropathy, if present must be < grade 1 by NCI criteria.

- Radionuclide bone scan and chest /abdominal/pelvic CT scan must be obtained in all
patients within 4 weeks prior to cycle 1/day 1.

- Sexually active men must be willing to consent to using effective contraception while
on treatment and for 6 months following treatment.

- No concomitant use of prostata or saw palmetto.

- Testosterone must be castrate levels(< 50 ng/ml).

- WBC > 2.8 x 109/L

- Granulocytes > 1.5 x 109/L

- Platelets > 100 x 109/L

- Hemoglobin > 8.0 g/dL

- Serum creatinine < 2.1

- Total bilirubin < ULN

- Alkaline Phosphatase < 2.5 ULN AND ALT/AST < 2.0 ULN OR Alkaline Phosphatase
2.6-3.9 ULN, AND ALT/AST <1.5 ULN OR Patients with known bone involvement may be
included with alkaline phosphatase > 4.0 ULN, IF ALT and AST and total bilirubin are
within the normal range and the bone involvement is thought to account for elevated
alkaline phosphatase.

- PT, INR should be within physiologic limits, i.e. INR 0.7 - 1.5. If patient is
receiving anticoagulation therapy then INR should be within the range of 2.0 - 3.5.

Exclusion Criteria

- Any major surgery or radiotherapy, within 4 weeks prior to cycle 1/day 1 (within 12
weeks for previous treatment with strontium-89, rhenium, or sumarium).

- Hormonal therapy, with the exception of androgen deprivation therapy and stable
regimens of prednisone and dexamethasone, (no change within 2 weeks prior to
cycle1/day 1). Prior prostate hormonal treatment must have been discontinued at least
four weeks (6 weeks for Casodex) prior to cycle1/day 1.

- Cardiovascular: Uncontrolled hypertension (resting blood pressure >160/100 mm/Hg);
clinical episodes of congestive heart failure, angina pectoris, or myocardial
infarction within the last year.

- Any active infections (requiring IV antibiotics).

- Any prior chemotherapy.

- Not reliable for adequate follow-up.

- History of severe hypersensitivity reaction to drugs formulated with polysorbate 80.

- Brain metastases or (clinical signs of) brain involvement or leptomeningeal disease.

- Patients with a history of another malignancy during the last 5 years other than
prostate cancer, nonmelanomatous skin cancer or in situ bladder cancer (Stage T1a).

- Concurrent commercial or investigational antineoplastic therapy.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

During the primary phase of the study (cycles 1-9), response to the combination of Taxotere® and Tarceva™ treatment will be assessed at the end of every 3 treatment cycles (9 weeks) with the standard procedures such as physical examination, CT scans, bone scans, MRI and laboratory results. For those patients that continue on in the extension phase of the study (cycles 10 -17), response to Tarceva™ is to be assessed at the end of 4 treatment cycles (end of cycle 13).

Outcome Time Frame:

9 weeks

Safety Issue:


Principal Investigator

Allan Pantuck, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2004

Completion Date:

March 2008

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • Prostatic Neoplasms



University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Los Angeles, California  90048-1865
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781