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Phase I/II Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma (Al-PCa)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Phase I/II Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma (Al-PCa)


OBJECTIVES:

- Determine the maximum tolerated dose of paclitaxel and thalidomide administered with
estramustine in patients with progressive metastatic androgen-independent prostate
cancer.

- Determine the efficacy of this regimen in these patients.

- Determine the objective response rate and prostate-specific antigen response rate in
patients treated with this regimen.

- Determine time to disease progression, performance status, analgesic consumption, and
survival of patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a phase I dose-escalation study of paclitaxel and thalidomide followed by a
phase II study.

- Phase I: Patients receive oral estramustine three times daily on days 1-5 and 8-12,
oral thalidomide once daily on days 1-21, and paclitaxel IV over 3 hours on days 3 and
10. Courses repeat every 21 days in the absence of disease progression or unacceptable
toxicity.

Cohorts of 3-6 patients receive escalating doses of paclitaxel and thalidomide until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

- Phase II: Patients receive paclitaxel, estramustine, and thalidomide as in arm I at the
MTD.

PROJECTED ACCRUAL: A total of 48-75 patients (18 for phase I and 30-57 for phase II) will be
accrued for this study within 8-15 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma* of the prostate

- Biopsy of a metastatic site allowed provided the tissue stains positive for
prostate-specific antigen (PSA)

- Indicator lesions need not be biopsy proven if the clinical presentation is
characteristic

- Nodal and/or visceral disease allowed NOTE: *Variant histologies (e.g., ductal
carcinoma and small cell carcinoma) are allowed only for the phase I portion of
the study

- Progressive androgen-independent disease, as evidenced by the following:

- Testosterone ≤ 50 ng/dL OR prior bilateral orchiectomy

- Patients must continue luteinizing hormone-releasing hormone agonists to
maintain castrate levels

- Symptomatic progression OR rising PSA on two occasions, at least 1 week apart,
with a minimum pretreatment PSA of 5 ng/mL

- Progressive disease after at least 1, but no more than 2, prior chemotherapy regimens
for prostate cancer in the neoadjuvant or metastatic setting (phase II only)

- No CNS metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- At least 12 weeks

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.0 g/dL

Hepatic

- SGOT and SGPT < 2 times upper limit of normal (ULN)

- Bilirubin < 2 times ULN

Renal

- Creatinine ≤ 2.0 mg/dL OR

- Creatinine clearance ≥ 35 mL/min

Cardiovascular

- No clinical history of heart disease

- ECG normal OR

- Ejection fraction ≥ 45% by echocardiogram, MUGA, or ventriculography

Other

- No active or uncontrolled infection

- No significant psychiatric disorder that would preclude giving informed consent

- No grade 2 or greater peripheral neuropathy

- No other malignancy within the past 5 years except superficial bladder cancer or
basal cell skin cancer

- No other serious medical illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 2 weeks since prior immunotherapy AND evidence of disease progression

- More than 2 weeks since prior antiangiogenesis therapy AND evidence of disease
progression

Chemotherapy

- See Disease Characteristics

- No more than 2 prior chemotherapy* regimens for prostate cancer

- More than 3 weeks since prior chemotherapy and recovered

- Prior taxanes allowed NOTE: *Ketoconazole is considered chemotherapy

Endocrine therapy

- See Disease Characteristics

- At least 4 weeks since prior flutamide or nilutamide (6 weeks for bicalutamide) AND
no evidence of response or disease progression since withdrawal

- No concurrent antiandrogens (e.g., flutamide, nilutamide or bicalutamide)

Radiotherapy

- More than 12 weeks since prior strontium chloride Sr 89

- No more than 1 prior dose of strontium chloride Sr 89

- More than 3 weeks since prior radiotherapy

- No prior radiotherapy to more than 15% of the bone marrow

Surgery

- See Disease Characteristics

- At least 2 weeks since prior surgery

Other

- More than 2 weeks since prior non-androgen mediated pathway therapy (e.g., epidermal
growth factor receptor antagonists or farnesyl transferase inhibitors) AND evidence
of disease progression

- More than 2 weeks since prior herbal or alternative medicines or PC-SPES AND evidence
of disease progression

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Danai Daliani

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000355825

NCT ID:

NCT00082693

Start Date:

March 2001

Completion Date:

Related Keywords:

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

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009