Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258284
• Other study ID #: CDR0000445613
• Secondary ID: P30CA022453WSU-D
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2005
• Last updated: March 5, 2014
• Start date: August 2003
• Est. completion date: November 2007

Study information

• Verified date: March 2014
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate by RECIST criteria after every 2 courses		at cycle 2 and every other cycle thereafter	No
Secondary	Toxicity at 30 days after last treatment		Every week during treatment cycles	Yes
Secondary	Progression-free survival		Every 2 cycles	No
Secondary	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	No
Secondary	Overall survival		Every 2 cycles	No
Secondary	Effect of treatment on biological correlates (thymidine phosphorylase, dihydropyrimidine dehydrogenase, thymidylate synthase)		Every week during treatment cycles	No