Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer
Information source: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: capecitabine (Drug); docetaxel (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Barbara Ann Karmanos Cancer Institute Official(s) and/or principal investigator(s): Ulka N. Vaishampayan, MD, Study Chair, Affiliation: Barbara Ann Karmanos Cancer Institute
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.
Clinical Details
Official title: Phase II Trial of Capecitabine (Xeloda) and Weekly Docetaxel (Taxotere) in Metastatic Androgen Independent Prostate Carcinoma
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Response rate by RECIST criteria after every 2 courses
Secondary outcome: Toxicity at 30 days after last treatmentProgression-free survival Time to treatment failure Overall survival Effect of treatment on biological correlates (thymidine phosphorylase, dihydropyrimidine dehydrogenase, thymidylate synthase)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: August 2003
Last updated: March 5, 2014
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