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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate by RECIST criteria after every 2 courses

Outcome Time Frame:

at cycle 2 and every other cycle thereafter

Safety Issue:

No

Principal Investigator

Ulka N. Vaishampayan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000445613

NCT ID:

NCT00258284

Start Date:

August 2003

Completion Date:

May 2008

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • stage IV prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201