Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Adenocarcinoma

Recurrence

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Infective Agents

Dexamethasone

Androgens

Doxorubicin

Liposomal doxorubicin

Docetaxel

Prednisone

Dexamethasone acetate

BB 1101

Vinblastine

Ketoconazole

Estramustine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Clotrimazole

Miconazole

Antifungal Agents

Cytochrome P-450 Enzyme Inhibitors

Cytochrome P-450 CYP3A Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Doxorubicin IV over 24 hours day 1; Oral ketoconazole 3 x daily on days 1-7 of weeks 1, 3, and 5; Vinblastine IV over 30 minutes Day 1, oral Estramustine 3 x daily on Days 1-7 of weeks 2, 4, and 6.

Oral Prednisone 2 x daily on days 1-21 (days 1-14 of course 5 only) and Docetaxel IV over 1 hour Day 1.

Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.

75 mg/m2 intravenous piggyback (IVPB) over 1 hour, Day 1, every 3 weeks.

Doxorubicin hydrochloride

140 mg orally 3 x day, Days 1 through 7 on Weeks 2, 4, 6

Estramustine phosphate sodium

400 mg orally (po) 3 x day, Days 1 through 7

Strontium chloride Sr 89

4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel.

Shi-Ming Tu, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radioactive substances such as strontium-89 may relieve bone pain associated with prostate cancer. It is not yet known whether chemotherapy is more effective with or without strontium-89 in treating bone metastases.

PURPOSE: This randomized phase III trial is studying giving chemotherapy together with strontium-89 to see how well it works compared to chemotherapy alone in treating patients with prostate cancer that has spread to the bone.

OBJECTIVES:

* Compare the effectiveness, in terms of overall survival, of consolidation therapy with or without strontium chloride Sr 89 after induction chemotherapy in patients with androgen-independent prostate cancer.

OUTLINE: This is a randomized study. Patients are stratified according to type of induction chemotherapy (KAVE vs prednisone and docetaxel), number of bony metastases (no more than 20 vs more than 20), Eastern Cooperative Oncology (ECOG) performance status (0-1 vs 2-3), and use of zoledronate (yes vs no).

* Induction therapy: Patients receive 1 of 2 induction therapy regimens.

  * Regimen A (KAVE): Patients receive doxorubicin IV over 24 hours on day 1 and oral ketoconazole three times daily on days 1-7 of weeks 1, 3, and 5. Patients receive vinblastine IV over 30 minutes on day 1 and oral estramustine three times daily on days 1-7 of weeks 2, 4, and 6. Patients receive no treatment on weeks 7 and 8. Treatment repeats every 8 weeks for at least 2 courses\* in the absence of disease progression or unacceptable toxicity.

NOTE: \*Patients continue to receive oral ketoconazole three times daily until disease progression.

* Regimen B (prednisone and docetaxel): Patients receive oral prednisone twice daily on days 1-21 (days 1-14 of course 5 only) and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for at least 5 courses in the absence of disease progression or unacceptable toxicity.

  * Consolidation therapy: Patients with a prostate-specific antigen (PSA) response (at least 50% decline in PSA level from baseline at week 16 OR at least 2 PSA levels decreased at least 50% from baseline) are randomized to 1 of 2 consolidation treatment arms.
* Arm I: Patients receive doxorubicin IV over 24 hours once weekly for 6 weeks plus strontium chloride Sr 89 IV once at the beginning of chemotherapy.
* Arm II: Patients receive doxorubicin as in arm I. Patients are followed every 4 weeks until PSA progression and then every 3 months thereafter.

PROJECTED ACCRUAL: Approximately 480 patients (240 randomized) will be accrued for this study within 48 months.

Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer

A Prospective Randomized Phase III, Trial Comparing Consolidation Therapy With or Without Strontium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer

Overall survival (OS) was computed using the number of months from the date of randomization to the date of death. Participants still alive were censored at the last follow-up date. Kaplan-Meier methodology was used to evaluate OS.

Overall survival (OS) was computed using the number of months from the date of registration to the date of death. Participants still alive were censored at the last follow-up date. Kaplan-Meier methodology was used to evaluate OS.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Induction treatment option 1 or induction treatment option 2.

Induction Treatment

Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.

Induction Treatment + Strontium-89

Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin 20mg/m\^2 IV over 24 hours once weekly for 6 weeks.

Induction Treatment + No Strontium-89

Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m\^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m\^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m\^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel.

Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m\^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m\^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m\^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.

Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m\^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m\^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m\^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin 20mg/m\^2 IV over 24 hours once weekly for 6 weeks.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Of the 265 participants enrolled - 133 participants received only induction treatment and 127 were randomized to either the Sr-89 treatment arm or the no Sr-89 treatment arm. 5 participants never received any treatment.

Shi-Ming Tu, MD/Professor, Genitourinary Medical Oncology

Overall Survival From Randomization

Overall Survival From Registration

Overall Study

Neoplasm Metastasis

Pain

strontium chloride Sr 89

G. O. N. Oosterhof, MD, PhD

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of strontium or radiation therapy in treating patients with prostate cancer that is refractory to hormone therapy who have painful bone metastases.

OBJECTIVES: I. Compare, in a randomized Phase III setting, the subjective response rate, time to progression, and survival of patients with hormone-refractory prostate cancer with painful osseous metastases treated with either strontium-89 or palliative local radiotherapy. II. Compare the quality of life achieved on these two regimens. III. Determine the toxicity and morbidity of treatment on these two regimens. IV. Compare the cost effectiveness of these two regimens.

OUTLINE: Randomized study. Arm I: Radioisotope therapy. Strontium-89 chloride, Strontium-89. Arm II: Radiotherapy. Involved-field irradiation (equipment unspecified).

PROJECTED ACCRUAL: 200 patients will be entered over 2 years.

Strontium Compared With Radiation Therapy in Treating Patients With Hormone-Refractory Prostate Cancer With Painful Bone Metastases

A PROSPECTIVE MULTICENTER RANDOMIZED STUDY COMPARING STRONTIUM-89 CHLORIDE AND PALLIATIVE LOCAL FIELD RADIOTHERAPY IN PATIENTS WITH HORMONAL ESCAPED ADVANCED PROSTATIC CANCER

European Organisation for Research and Treatment of Cancer - EORTC

Antirheumatic Agents

Analgesics

Celecoxib

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Doxorubicin IV over 30 minutes on days 1, 8, 15, and 22 + Strontium chloride Sr 89 IV on day 1, and oral celecoxib twice daily in absence of disease progression.

Doxorubicin IV over 30 minutes on days 1, 8, 15, and 22 + Strontium chloride Sr 89 IV on day 1.

Oral celecoxib twice daily in the absence of disease progression.

By vein (IV) over 30 minutes on days 1, 8, 15, and 22

Doxorubicin Hydrochloride

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Strontium-89 may relieve bone pain caused by prostate cancer. Celecoxib may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Combining doxorubicin and strontium-89 with celecoxib may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying celecoxib together with doxorubicin and strontium-89 to see how well they work compared to doxorubicin and strontium-89 alone in treating patients with progressive androgen-independent prostate cancer and bone metastases.

OBJECTIVES:

* Compare time to prostate-specific antigen progression in patients with progressive androgen-independent prostate cancer and bone metastases treated with doxorubicin and strontium chloride Sr 89 with or without celecoxib.

OUTLINE: This is a randomized study. Patients are stratified according to extent of bone metastases on bone scan (\> 20 lesions vs ≤ 20 lesions) and quality of response (i.e., decline of the prostate-specific antigen from baseline) to prior induction chemotherapy (≥ 80% vs \< 80%). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive doxorubicin IV over 30 minutes on days 1, 8, 15, and 22 and strontium chloride Sr 89 IV on day 1. Patients also receive oral celecoxib twice daily in the absence of disease progression.
* Arm II: Patients receive doxorubicin and strontium chloride Sr 89 as in arm I.

PROJECTED ACCRUAL: A total of 70 patients (35 per treatment arm) will be accrued for this study within 18 months.

Doxorubicin and Strontium-89 With or Without Celecoxib in Treating Patients With Progressive Androgen-Independent Prostate Cancer and Bone Metastases

A Randomized Phase II Trial of Bone-Targeted Therapy Consisting of Strontium-89 and Doxorubicin With or Without Celecoxib in Androgen-Independent Prostate Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer	NCT00024167	Prostate Cancer	Docetaxel Doxorubicin hyd... Estramustine ph... Ketoconazole Prednisone Vinblastine Strontium chlor... Dexamethasone	18 Years -	M.D. Anderson Cancer Center
Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer	NCT00024167	Prostate Cancer	Docetaxel Doxorubicin hyd... Estramustine ph... Ketoconazole Prednisone Vinblastine Strontium chlor... Dexamethasone	18 Years -	M.D. Anderson Cancer Center
Strontium Compared With Radiation Therapy in Treating Patients With Hormone-Refractory Prostate Cancer With Painful Bone Metastases	NCT00002503	Metastatic Canc... Prostate Cancer	strontium chlor...	-	European Organisation for Research and Treatment of Cancer - EORTC
Doxorubicin and Strontium-89 With or Without Celecoxib in Treating Patients With Progressive Androgen-Independent Prostate Cancer and Bone Metastases	NCT00080782	Metastatic Canc... Prostate Cancer	Celecoxib Doxorubicin Hyd... Strontium chlor...	-	M.D. Anderson Cancer Center

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