Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma

NCT00038246 | Completed Phase 1 DMC

• 1 other identifier: ID00-087
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The three study drugs (Thalidomide, Taxol, and Estramustine) used in this study are all chemotherapy drugs used in shrinking the cancer.

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) Thalidomide

  MTD defined by Continuous reassessment method.

  21 day cycles

Study Arms (1)

Thalidomide, Taxol, Estramustine

EXPERIMENTAL

Thalidomide starting dose 200 mg by mouth every day once a week; Taxol 100 mg/m\^2 by vein (IV) over 3 hours Day 3 and Day 10; Estramustine 140 mg by mouth three times a day on Days 1-5, 8-12.

Drug: Estramustine; Drug: Thalidomide; Drug: Paclitaxel (Taxol)

Interventions

Estramustine DRUG

140 mg by mouth (po) three times a day on Days 1-5, 8-12

Also known as: Emcyt, Estramustine Phosphate

Thalidomide, Taxol, Estramustine

Thalidomide DRUG

200 mg by mouth every day once a week with dose escalation every week if no dose limiting toxicity.

Also known as: Thalomid

Thalidomide, Taxol, Estramustine

Paclitaxel (Taxol) DRUG

100 mg/m\^2 by vein (IV) over 3 hours Day 3 and Day 10

Thalidomide, Taxol, Estramustine

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Histologic demonstration of adenocarcinoma of the prostate. Patients with variant histologies (ductal carcinoma, small cell carcinoma) are eligible only for the Phase I part of the trial, but are excluded from the Phase II. If no sample of the primary tumor was obtained, biopsy of a metastatic site is sufficient if the tissue stains positive for PSA. Some pathologic material must be available for review. Indicator need not be biopsy proven if the clinical presentation is characteristic.
• Androgen-Independent progression of prostate carcinoma, as shown by:
• Serum testosterone level of \< 50 ng/dL or prior bilateral orchiectomy. Treatment to maintain castrate levels of testosterone (LHRH agonists) should continue, and
• Either symptomatic progression, or, if patient is asymptomatic, then a rising serum PSA in two occasions at least 1 week apart, with a minimum pre-treatment serum PSA of 5.
• Patients must be off anti-androgens, such as flutamide (Eulexin), bicalutamide (Casodex) or nilutamide (Nilandron). They must have no evidence of response at least 4 weeks (6 weeks for bicalutamide) since anti-androgen withdrawal (or progression at any time since anti-androgen withdrawal).
• Patients with nodal and/or visceral disease are eligible.
• Patients may have up to 2 prior chemotherapy regimens for prostate cancer, provided that more than 3 weeks have elapsed since the last treatment and patients have recovered from toxicity. Ketoconazole is considered chemotherapy. Prior Taxanes are allowed in both the Phase I and Phase II part of the trial. For the Phase II part of the study, patients must have progressed after \>/= 1 and \</= 2 prior chemotherapy regimens for prostate cancer (as neoadjuvant treatment or for metastatic disease).
• Up to one prior dose of Strontium-89 (Metastron) is allowed, if given more than 12 weeks prior to study entry. Patients may have had radiation therapy involving \< 15% of the bone marrow (completed more than 3 weeks of initiation of the study).
• Previous treatment with PC-SPES, herbal / alternative medicines, anti-angiogenesis inhibitors, immunotherapy, or other non-androgen mediated pathways (such as epidermal growth factor receptor antagonists or farnesyl transferase inhibitors) is allowed, provided that there is unequivocal evidence of disease progression since completion of the therapy and more than 2 weeks have elapsed since last treatment.
• Patients must be at least 2 weeks from prior surgery.
• Adequate physiologic reserve as evidenced by:
• Life expectancy of at least 12 weeks
• Zubrod performance status of \< 2.
• Age \> 18 years old.

You may not qualify if:

• Patients with variant histologies (ductal or small cell carcinoma) are excluded from the phase II part of the trial (are eligible for the phase I part).
• Patients with no prior chemotherapy for prostate cancer are excluded from the phase II part of the study.
• Patients with central nervous system (CNS) metastases or serious medical illnesses, active or uncontrolled infections, significant psychiatric disorders that preclude giving informed consent, patients with NCI grade \> 2 peripheral neuropathy or patients with a history of another malignancy (except from superficial bladder cancer or basal cell carcinoma of the skin) within 5 years prior to study entry are excluded from the trial.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Celgene: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Estramustine; Thalidomide; Paclitaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes

Study Officials

• Christopher J. Logothetis, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2002
• First Posted: May 30, 2002
• Study Start: October 1, 2000
• Primary Completion: February 1, 2004
• Study Completion: December 1, 2004
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

US (1)