NCT00087035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started May 2004

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

August 3, 2020

Status Verified

August 1, 2012

Enrollment Period

2.1 years

First QC Date

July 8, 2004

Last Update Submit

July 30, 2020

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostaterecurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Response

    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).

    9 weeks

Secondary Outcomes (1)

  • Safety and tolerability based on adverse events, laboratory tests and physical exams

    9 weeks

Study Arms (1)

Taxotere plus Tarceva

EXPERIMENTAL

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: docetaxelDrug: erlotinib hydrochloride

Interventions

docetaxelDRUG

Administered as an IV infusion of 60m/m2 over a 1-hour period, once every 21 ± 2 days

Also known as: Taxotere
Taxotere plus Tarceva
erlotinib hydrochlorideDRUG

Will be taken at a starting daily dose of 150mg

Also known as: Tarceva
Taxotere plus Tarceva

Eligibility Criteria

Age65 Years+
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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
  • +5 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

DocetaxelErlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Allan Pantuck, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2004

First Posted

July 12, 2004

Study Start

May 1, 2004

Primary Completion

June 1, 2006

Study Completion

March 1, 2008

Last Updated

August 3, 2020

Record last verified: 2012-08

Locations

US(3)