Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Cancer and Leukemia Group B.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Cancer and Leukemia Group B
Collaborator:
Information provided by (Responsible Party):
Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:
NCT00016913
First received: June 6, 2001
Last updated: April 10, 2012
Last verified: April 2011
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin or leuprolide may stop the adrenal glands from producing androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, hormone therapy, and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying giving chemotherapy together with hormone therapy and radiation therapy in treating patients with locally advanced prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: carboplatin Drug: estramustine Drug: paclitaxel Radiation: radiation therapy Drug: leuprolide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study Of Neo-Adjuvant Paclitaxel, Estramustine And Carboplatin (TEC) Plus Androgen Ablation Prior To Radiation Therapy In Patients With Poor Prognosis Localized Prostate Cancer |
Resource links provided by NLM:
Drug Information available for:
Paclitaxel
Carboplatin
Estramustine phosphate sodium
Leuprolide acetate
U.S. FDA Resources
Further study details as provided by Cancer and Leukemia Group B:
Primary Outcome Measures:
- Toxicity [ Time Frame: 90 days and 1 year post tx ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Time to prostate-specific antigen failure [ Time Frame: Wk 1 ea chemotx cycle & in follow up ] [ Designated as safety issue: No ]Follow up is q 3 mon for 2 yrs then q 6 mon for 4 years
- Progression-free survival [ Time Frame: registration to progression ] [ Designated as safety issue: No ]progression includes PSA, local or distant ds, or death
- Overall survival [ Time Frame: 6 years post treatment ] [ Designated as safety issue: No ]
| Enrollment: | 34 |
| Study Start Date: | May 2001 |
| Estimated Study Completion Date: | January 2013 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Neo-Adj ChemoTx + ablation prior to RT
Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
|
Drug: carboplatin
AUC=6 week one of each 4 week cycle
Drug: estramustine
2 tablets tid PO 5 of 7 days per week each 4 week cycle
Drug: paclitaxel
80 mg/sq m IV infusion over 1 hour weekly for ea 4 week cycle
Radiation: radiation therapy
77.4 Gy in 1.8 Gy fractions
Drug: leuprolide
7.5 mg IM injection once every 4 weeks for 6 months
Other Name: GnRH
|
Detailed Description:
OBJECTIVES:
- Determine the feasibility and safety of paclitaxel, estramustine, carboplatin, and androgen ablation followed by radiotherapy in patients with poor-prognosis locally advanced prostate cancer.
- Determine the progression-free survival and time to prostate specific antigen failure in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 1 hour once weekly; oral estramustine three times a day, five days a week; and carboplatin IV over 1 hour once monthly. Treatment repeats every 4 weeks for 4 courses.
Patients also receive gonadotropin-releasing hormonal therapy comprising either goserelin subcutaneously or leuprolide intramuscularly once monthly. Treatment repeats every 4 weeks for 6 courses.
After the completion of chemotherapy, patients undergo radiotherapy once daily on weeks 17-24.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1.5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate with one of the following prognostic factors:
- Tx N0, baseline prostate specific antigen (PSA) greater than 20 ng/mL, and Gleason score at least 7
- T3b-4 N0, any baseline PSA, and any Gleason score
- No pelvic lymph node disease requiring pelvic radiotherapy
- No metastatic disease by bone scan, CT scan, or MRI
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 1.5 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No significant cardiovascular disease
- No New York Heart Association class III or IV congestive heart failure
- No active angina pectoris
- No myocardial infarction within the past 6 months
- No history of hemorrhagic or thrombotic cerebral vascular accident
- No deep vein thrombosis within the past 6 months
Pulmonary:
- No pulmonary embolism within the past 6 months
Other:
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy for prostate cancer
- No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy:
- No prior chemotherapy for prostate cancer
- No other concurrent anticancer chemotherapy
Endocrine therapy:
- No more than 6 weeks of prior androgen deprivation therapy
- No other concurrent anticancer hormonal therapy except steroids for adrenal failure and/or hormones for nondisease-related conditions (e.g., insulin for diabetes)
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy for prostate cancer
- No other concurrent anticancer radiotherapy
Surgery:
- At least 4 weeks since prior major surgery
Other:
- No prior alternative therapy (e.g., PC-SPES) for prostate cancer
- No concurrent alternative medicine (e.g., PC-SPES or saw palmetto) or large quantities of vitamins
- No other concurrent anticancer therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016913
Locations
| United States, District of Columbia | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5001 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| Veterans Affairs Medical Center - Baltimore | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| UMASS Memorial Cancer Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Missouri | |
| Saint Luke's Hospital | |
| Chesterfield, Missouri, United States, 63017 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| University Medical Center of Southern Nevada | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Oswego Hospital | |
| Oswego, New York, United States, 13126 | |
| CCOP - Hematology-Oncology Associates of Central New York | |
| Syracuse, New York, United States, 13057 | |
| Community General Hospital of Greater Syracuse | |
| Syracuse, New York, United States, 13215 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| Veterans Affairs Medical Center - Syracuse | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Wayne Radiation Oncology | |
| Goldsboro, North Carolina, United States, 27534 | |
| Wayne Memorial Hospital, Incorporated | |
| Goldsboro, North Carolina, United States, 27534 | |
| Lenoir Memorial Cancer Center | |
| Kinston, North Carolina, United States, 28501 | |
| Wilson Medical Center | |
| Wilson, North Carolina, United States, 27893-3428 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| United States, South Carolina | |
| Roper St. Francis Cancer Center at Roper Hospital | |
| Charleston, South Carolina, United States, 29401 | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| Bon Secours St. Francis Health System | |
| Greenville, South Carolina, United States, 29601 | |
| United States, Virginia | |
| Danville Regional Medical Center | |
| Danville, Virginia, United States, 24541 | |
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
| Study Chair: | William K. Kelly, DO | Yale University |
More Information
Additional Information:
Publications:
| Responsible Party: | Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00016913 History of Changes |
| Other Study ID Numbers: | CDR0000068632, U10CA031946, CALGB-99811 |
| Study First Received: | June 6, 2001 |
| Last Updated: | April 10, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Cancer and Leukemia Group B:
|
adenocarcinoma of the prostate stage III prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Estramustine Leuprolide Carboplatin Paclitaxel Antineoplastic Agents, Hormonal Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013