Docetaxel and Erlotinib in Treating Older Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00087035
Recruitment Status : Completed
First Posted : July 12, 2004
Last Update Posted : October 2, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining docetaxel with erlotinib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel together with erlotinib works in treating older patients with progressive prostate cancer that has not responded to hormone therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: docetaxel Drug: erlotinib hydrochloride Phase 2

Detailed Description:



  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Of TAXOTERE + TARCEVA™ To Treat HRPC In Men ≥ 65 Years Of Age
Study Start Date : May 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Taxotere plus Tarceva

Patients receive Tarceva 150 mg daily for 21 consecutive days (one treatment cycle). In addition, all patients will receive single agent Taxotere 60 mg/m2 IV over 1 hour infusion every 21 ± 2 days and have it administered on day 1.

Taxotere + Tarceva to be taken for three cycles past maximal response or until one of the following occurs: 1) a drug-related toxicity requiring discontinuation, 2) disease progression, or 3) for a maximum of 9 cycles.

Upon completion of 9 cycles of Taxotere plus Tarceva, patients showing evidence of objective response (CR, PR or stable disease) may continue in the extension phase of the study and receive treatment with Tarceva alone. Treatment response evaluated after four cycles of Tarceva treatment(immediately prior to cycle 14). Patients with progression of disease will be taken off study. Responding and stable disease patients will remain on study for up to 8 extension-phase cycles for a total of 17 cycles.

Drug: docetaxel
Administered as an IV infusion of 60m/m2 over a 1-hour period, once every 21 ± 2 days
Other Name: Taxotere

Drug: erlotinib hydrochloride
Will be taken at a starting daily dose of 150mg
Other Name: Tarceva

Primary Outcome Measures :
  1. Response [ Time Frame: 9 weeks ]
    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).

Secondary Outcome Measures :
  1. Safety and tolerability based on adverse events, laboratory tests and physical exams [ Time Frame: 9 weeks ]

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00087035

United States, California
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
United States, Washington
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Allan Pantuck, MD Jonsson Comprehensive Cancer Center

Responsible Party: Jonsson Comprehensive Cancer Center Identifier: NCT00087035     History of Changes
Other Study ID Numbers: CDR0000372833
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2004    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: August 2012

Keywords provided by Jonsson Comprehensive Cancer Center:
adenocarcinoma of the prostate
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors