Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

Phase II Trial of Capecitabine (Xeloda) and Weekly Docetaxel (Taxotere) in Metastatic Androgen Independent Prostate Carcinoma

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: capecitabine; Drug: docetaxel

Detailed Description

OBJECTIVES:

Primary

• Determine the response rate in patients with androgen-independent metastatic adenocarcinoma of the prostate treated with capecitabine and docetaxel.

Secondary

• Determine the toxicity of this regimen in these patients.
• Determine the progression-free survival, time to treatment failure, and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

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

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201-1379
      • Barbara Ann Karmanos Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Docetaxel & Capecitabine; 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; 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; Other Names: Xeloda®; Drug: docetaxel; 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; Other Names: Taxotere®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate by RECIST criteria after every 2 courses	at cycle 2 and every other cycle thereafter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity at 30 days after last treatment		Every week during treatment cycles
Progression-free survival		Every 2 cycles
Time to treatment failure	From date of registration to date of progressive disease, or date patient is taken off study for any other reason.	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

Collaborators and Investigators

• Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Ulka N. Vaishampayan, MD, Barbara Ann Karmanos Cancer Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: November 22, 2005
• First Submitted That Met QC Criteria: November 22, 2005
• First Posted (Estimate): November 24, 2005

Study Record Updates

• Last Update Posted (Estimate): March 6, 2014
• Last Update Submitted That Met QC Criteria: March 5, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: stage IV prostate cancer; recurrent prostate cancer; adenocarcinoma of the prostate
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Capecitabine
• Other Study ID Numbers: CDR0000445613; P30CA022453 (U.S. NIH Grant/Contract); WSU-D-2615; WSU-HIC-067903MP4F