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Safety and Efficacy Study of GM-CSF, Thalidomide Plus Docetaxel in Prostate Cancer

Primary Purpose

Prostatic Neoplasms

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

GM-CSF

thalidomide

docetaxel

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Prostate Cancer, Hormone-Naïve Prostate Cancer, adenocarcinoma of the prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of adenocarcinoma of the prostate.
Failure of local treatments (surgery and/or radiation) as defined by a rising PSA; demonstrated by at least three consecutive rises in PSA by intervals of at least 4 weeks apart with an absolute change of at least 1 ng/mL. If the confirmatory PSA (third PSA) is less than the previous screening PSA value, an additional test for rising PSA will be required to document progression.
No clinical or radiographic evidence of disease.
The Zubrod performance status 0-1.
Prior hormonal therapy in the form of neoadjuvant or adjuvant therapy is allowed as long as androgen therapy has been completed at least 1 year prior to study entry.
Adequate hematologic function: absolute granulocytes ≥ 1500/ul, platelets ≥ 100,000/ul, hemoglobin ≥ 10 gm/100 ml within 4 weeks prior to study entry.
Adequate hepatic function: bilirubin ≤ 1.5 mg/dl, liver enzymes ≤ 1.5 ULN within 4 weeks prior to study entry.
Adequate renal function: creatinine ≤ 1.5 x ULN within 4 weeks prior to study entry.
Patients treated with bisphosphonate therapy before or after study entry are eligible to continue in the study.
Negative bone scan within 6 weeks prior to study entry.
Negative CT scan or MRI of the abdomen and pelvis within 6 weeks prior to study entry.
Negative chest x-ray for metastatic disease within 6 weeks prior to study entry.
Patients must sign a written informed consent prior to treatment.

Exclusion Criteria:

Serious intercurrent medical illness including symptomatic heart disease within 6 months.
Previous or concurrent invasive cancers other than superficial non-melanomatous skin cancer unless disease-free for at least 5 years.
Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
History of thromboembolic events (deep venous thrombosis, symptomatic cerebrovascular events or pulmonary embolism), history of MI, within the last 12 months.
History of bleeding disorders that would contraindicate Coumadin® (warfarin) including: esophageal varices and clotting factor defects

Sites / Locations

The Methodist Hospital Research Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm Description

Combination therapy of GM-CSF, Thalidomide plus Docetaxel in patients with prostate cancer with a rising PSA

Outcomes

Primary Outcome Measures

To assess the relative efficacy of the combination of GM-CSF, Thalidomide and Docetaxel in patients with prostate cancer.

PI relocated, no data currently available

Secondary Outcome Measures

Collect data on hormonal responses produced by GM-CSF, Thalidomide and Docetaxel.

PI relocated, no data currently available

Evaluate safety and toxicity of the combination of GM-CSF, Thalidomide and Docetaxel for patients with hormone naïve prostate cancer.

PI relocated, no data currently available

Full Information

NCT ID

NCT00450008

First Posted

March 19, 2007

Last Updated

March 15, 2016

Sponsor

The Methodist Hospital Research Institute

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00450008

Brief Title

Safety and Efficacy Study of GM-CSF, Thalidomide Plus Docetaxel in Prostate Cancer

Official Title

Phase II Study of Patients With Hormone-Naïve Prostate Cancer With a Rising Prostate Specific Antigen: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Thalidomide Plus Docetaxel

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Terminated

Why Stopped

PI decision

Study Start Date

December 2006 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Methodist Hospital Research Institute

Collaborators

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to assess the relative efficacy and toxicity of combination therapy of GM-CSF, Thalidomide plus Docetaxel in patients with prostate cancer with a rising PSA.

Detailed Description

As more men are being diagnosed and treated for prostate cancer at an early age, the number who experiences a rising level of prostate-specific antigen (PSA) after initial treatment is increasing, affecting approximately 50,000 patients each year. These three drugs are commercially available. Thalidomide is an angiogenesis inhibitor which blocks the development of new blood vessels. GM-CSF stimulates the body's immune response to fight cancer. Docetaxel is the most active chemotherapeutic agent in the treatment of prostate cancer. GM-CSF and thalidomide have proven activity in suppressing PSA values. This study design offers an opportunity to add cytotoxic therapy (docetaxel) in combination with an active pathobiologic regimen (GM-CSF plus thalidomide) to eradicate micrometastatic disease, thus potentially offering a significant delay to clinical failure as measured by a rise in PSA or radiographic involvement. Additionally, delays in the use of hormone therapy has the potential to be of significant benefit. GM-CSF will be administered at a fixed dose 3 days per week by subcutaneous injection for 12 months. Participants will receive a fixed dose of thalidomide orally at bedtime daily without interruption for 12 months. Docetaxel will be administered intravenously over 1 hour on week 1 of every cycle (every 3 weeks) for 18 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Neoplasms

Keywords

Prostate Cancer, Hormone-Naïve Prostate Cancer, adenocarcinoma of the prostate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

Combination therapy of GM-CSF, Thalidomide plus Docetaxel in patients with prostate cancer with a rising PSA

Intervention Type

Drug

Intervention Name(s)

GM-CSF

Other Intervention Name(s)

Leukine

Intervention Description

fixed dose of 250 mcg/m2, 3 days per week by subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

thalidomide

Other Intervention Name(s)

Thalomid

Intervention Description

Thalidomide by oral administration at a fixed dose of 200 mg. Prophylactic Coumadin® by oral administration at a fixed dose of 2.5 mg to prevent thromboembolic events (DVT and TIA/stroke) during Thalidomide administration. Thalidomide and Coumadin will be given daily at bedtime without interruption.

Intervention Type

Drug

Intervention Name(s)

docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

Docetaxel will be administered by intravenous piggyback over 1 hour at 75mg/m² every 3 weeks. Pre-medication for the docetaxel infusion will consist of dexamethasone 8 mg administered orally 12 hours, 3 hours and 1 hour before docetaxel.

Primary Outcome Measure Information:

Title

To assess the relative efficacy of the combination of GM-CSF, Thalidomide and Docetaxel in patients with prostate cancer.

Description

PI relocated, no data currently available

Time Frame

during study (no data currently available)

Secondary Outcome Measure Information:

Title

Collect data on hormonal responses produced by GM-CSF, Thalidomide and Docetaxel.

Description

PI relocated, no data currently available

Time Frame

during study (no data currently available)

Title

Evaluate safety and toxicity of the combination of GM-CSF, Thalidomide and Docetaxel for patients with hormone naïve prostate cancer.

Description

PI relocated, no data currently available

Time Frame

during study (no data currently available)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of adenocarcinoma of the prostate. Failure of local treatments (surgery and/or radiation) as defined by a rising PSA; demonstrated by at least three consecutive rises in PSA by intervals of at least 4 weeks apart with an absolute change of at least 1 ng/mL. If the confirmatory PSA (third PSA) is less than the previous screening PSA value, an additional test for rising PSA will be required to document progression. No clinical or radiographic evidence of disease. The Zubrod performance status 0-1. Prior hormonal therapy in the form of neoadjuvant or adjuvant therapy is allowed as long as androgen therapy has been completed at least 1 year prior to study entry. Adequate hematologic function: absolute granulocytes ≥ 1500/ul, platelets ≥ 100,000/ul, hemoglobin ≥ 10 gm/100 ml within 4 weeks prior to study entry. Adequate hepatic function: bilirubin ≤ 1.5 mg/dl, liver enzymes ≤ 1.5 ULN within 4 weeks prior to study entry. Adequate renal function: creatinine ≤ 1.5 x ULN within 4 weeks prior to study entry. Patients treated with bisphosphonate therapy before or after study entry are eligible to continue in the study. Negative bone scan within 6 weeks prior to study entry. Negative CT scan or MRI of the abdomen and pelvis within 6 weeks prior to study entry. Negative chest x-ray for metastatic disease within 6 weeks prior to study entry. Patients must sign a written informed consent prior to treatment. Exclusion Criteria: Serious intercurrent medical illness including symptomatic heart disease within 6 months. Previous or concurrent invasive cancers other than superficial non-melanomatous skin cancer unless disease-free for at least 5 years. Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up. History of thromboembolic events (deep venous thrombosis, symptomatic cerebrovascular events or pulmonary embolism), history of MI, within the last 12 months. History of bleeding disorders that would contraindicate Coumadin® (warfarin) including: esophageal varices and clotting factor defects

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert J Amato, DO

Organizational Affiliation

The Methodist Hospital Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Methodist Hospital Research Institute

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Safety and Efficacy Study of GM-CSF, Thalidomide Plus Docetaxel in Prostate Cancer

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