Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer

NCT00115635 | Completed Phase 1 DMC

• 2 other identifiers: UR0416EudraCT number: 2004-002353-31
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to determine the optimal dose of the combination of docetaxel and gemcitabine in patients with hormone refractory prostate cancer, and evaluate this dose with respect to efficacy and toxicity in a phase II trial.

Conditions

Prostate Cancer

Keywords

Hormonal refractory, chemotherapy, docetaxel, gemcitabine

Outcome Measures

Primary Outcomes (1)

• Prostate-specific antigen (PSA) response

Secondary Outcomes (3)

• Clinical response

• Time to PSA progression

• Toxicity

Interventions

docetaxel DRUG

gemcitabine DRUG

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically verified adenocarcinoma of the prostate.
• Hormone refractory prostate cancer (HRPC) defined as progression during previous anti-hormone treatment. Patients must have been off previous anti-androgen therapy for more than 4 weeks.
• Stage IV disease (verified by imaging or clinical examination).
• PSA \> 10 microgram/l.
• PSA progression defined as a \> 25% increase between two independent measurements performed with a 1-month interval or more after discontinuation of anti-androgen treatment.
• Castrate level of testosterone (\< 50 ng).
• No previous oestrogen or steroid as metastatic prostate cancer treatment.
• Satisfactory hepatic function in the form of total bilirubin ≤ UNL (upper normal limit), ASAT/ALAT ≤ 2.5 x UNL, alkaline phosphatase ≤ 5 x UNL.
• Satisfactory renal function, defined as serum creatinine ≤ 1.5 x UNL.
• Satisfactory haematologic function defined as ANC \>1.5 x 10\^9/l, leucocytes \>3.0 x 10\^9/l, thrombocytes ≥ 100 x 10\^9/l, haemoglobin \> 7 mmol/l
• ECOG performance status ≤ 2.
• Life expectancy \> 3 months.
• Patient must be able to adhere to protocol requirements.
• Written informed consent.
• \> 18 years of age.

You may not qualify if:

• Previous prostate cancer treatment with oestrogens or steroid hormones.
• Previous chemotherapy.
• Previous treatment with systemic radioactive isotopes.
• Bisphosphonate treatment (concomitant).
• Radiation therapy covering more than 25% of the bone marrow producing area.
• Other serious coincidental and/or concomitant medical condition.
• Symptomatic cerebral metastases.
• Other previous or current malignant disease, excluding \*adequately treated and cured planocellular skin carcinoma; or \*other cancer assessed to carry minimal risk of recurrence.
• ECOG performance status \> 2.

Sponsors & Collaborators

• Herlev Hospital: lead
• Sanofi: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Dept. of Oncology, 54B1, Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Lisa Sengelov, MD

  Dept. of Oncology, Herlev Hospital, 2730 Herlev, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 23, 2005
• First Posted: June 24, 2005
• Study Start: March 1, 2005
• Study Completion: July 1, 2007
• Last Updated: October 2, 2007

Record last verified: 2007-10

Locations

DK (1)