Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

NCT00258284 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000445613P30CA022453WSU-D-2615WSU-HIC-067903MP4F
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving capecitabine together with docetaxel works in treating patients with metastatic prostate cancer.

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer; stage IV prostate cancer; adenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

• Response rate by RECIST criteria after every 2 courses

  at cycle 2 and every other cycle thereafter

Secondary Outcomes (5)

• Toxicity at 30 days after last treatment

  Every week during treatment cycles

• Progression-free survival

  Every 2 cycles

• Time to treatment failure

  Every 2 cycles

• Overall survival

  Every 2 cycles

• Effect of treatment on biological correlates (thymidine phosphorylase, dihydropyrimidine dehydrogenase, thymidylate synthase)

  Every week during treatment cycles

Study Arms (1)

Docetaxel & Capecitabine

EXPERIMENTAL

Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR

Drug: capecitabine; Drug: docetaxel

Interventions

capecitabine DRUG

Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR

Also known as: Xeloda®

Docetaxel & Capecitabine

docetaxel DRUG

Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR

Also known as: Taxotere®

Docetaxel & Capecitabine

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Metastatic disease * Androgen-independent disease * Progressive disease, as documented by ≥ 1 of the following criteria: * Rising prostate-specific antigen (PSA) despite androgen deprivation therapy and anti-androgen withdrawal * Demonstrates a rising PSA trend with 2 successive elevations ≥ 1 week apart * Measurable disease progression * Nonmeasurable disease progression, defined as the following: * PSA ≥ 5 ng/mL * New areas of bone metastases on bone scan * Serum testosterone ≤ 0.5 ng/mL (castrate level) * Concurrent luteinizing hormone-releasing hormone agonist therapy required for medically castrated patients PATIENT CHARACTERISTICS: Performance status * Zubrod 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count ≥ 1,500/ mm\^3 * Hemoglobin ≥ 8.0 g/dL * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin normal * Transaminases meeting 1 of the following criteria: * AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase (AP) normal * AP ≤ 4 times ULN if AST and/or ALT normal Renal * Creatinine clearance ≥ 50 mL/min OR * Creatinine ≤ 2 mg/dL Cardiovascular * No congestive heart failure * No second- or third-degree heart block * No myocardial infarction within the past 3 months Other * Fertile patients must use effective contraception during and for 6 months after completion of study treatment * No other malignancy within the past 2 years except adequately treated skin cancer or other cancer in complete remission * No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No peripheral neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: Chemotherapy * No prior chemotherapy for metastatic disease Endocrine therapy * See Disease Characteristics * More than 4 weeks since prior flutamide * More than 6 weeks since prior bicalutamide or nilutamide Radiotherapy * At least 4 weeks since prior radiotherapy Other * At least 28 days since prior investigational drugs for prostate cancer * No other concurrent anti-cancer therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Capecitabine; Docetaxel

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)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Ulka N. Vaishampayan, MD

  Barbara Ann Karmanos Cancer Institute

  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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 24, 2005
• Study Start: August 1, 2003
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: March 6, 2014

Record last verified: 2014-03

Locations

US (1)