Clinical trial · Interventional
Docetaxel and Erlotinib in Treating Older Patients With Prostate Cancer
Phase II Trial Of TAXOTERE + TARCEVA™ To Treat HRPC In Men ≥ 65 Years Of Age
NCT00087035CI-TRIAL-00046376completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Taxotere plus Tarceva
- description
- 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.
- interventionNames
- Drug: docetaxel
- Drug: erlotinib hydrochloride
Primary outcomes (1)
- measure
- Response
- timeFrame
- 9 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.