Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Recurrence

Diarrhea

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Signs and Symptoms, Digestive

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Gastrointestinal Agents

Docetaxel

Prednisone

Taxane

Octreotide

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Patients receive cabazitaxel IV over 1 hour on day 1, prednisone PO QD, and octreotide pamoate IM on day 1. Patients also receive octreotide acetate SC TID on days 1-14 of course 1 only. Treatment with cabazitaxel repeats every 21 days and treatment with prednisone and octreotide pamoate repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.

cabazitaxel

prednisone

octreotide pamoate

questionnaire administration

octreotide acetate

Jacek Pinski

This phase II trial studies how well octreotide works in reducing diarrhea in patients receiving cabazitaxel and prednisone for hormone-resistant prostate cancer (HRPC) previously treated with docetaxel. Octreotide may prevent diarrhea by blocking the secretion of several hormones in patients receiving chemotherapy for prostate cancer

PRIMARY OBJECTIVES:

I. To evaluate the impact of octreotide in reducing the incidence of grade 2 or greater diarrhea in men receiving cabazitaxel plus prednisone for castration-resistant prostate cancer (CRPC) after docetaxel therapy.

SECONDARY OBJECTIVES:

I. Overall survival (OS).

II. Progression-free survival (PFS) (defined as the time between treatment start and the first date of progression as measured by objective tumor progression using the Response Evaluation Criteria In Solid Tumors (RECIST), pain progression or death).

III. Prostate-specific antigen (PSA) response rate.

IV. Objective response rate.

V. Pain response.

VI. Toxicity.

OUTLINE:

Patients receive cabazitaxel as intravenous (IV) infusion over 1 hour on day 1, prednisone by mouth (PO) every day (QD), and octreotide pamoate given as intramuscular (IM) injection on day 1. Patients also receive octreotide acetate as a subcutaneous (SC) injection three times a day (TID) on days 1-14 of course 1 only. Treatment with cabazitaxel repeats every 21 days and treatment with prednisone and octreotide pamoate repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1 month, every 3 months until disease progression, and then every 6 months thereafter.

Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel

A Phase II Clinical Trial of Cabazitaxel Plus Prednisone With Octreotide in the Treatment of Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel

Defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 criteria as an increase in frequency of 4 or greater stools per day over baseline, incontinence, diarrhea warranting hospitalization or diarrhea limiting self-care activities of daily living (ADL). Baseline frequency will be defined in the pre-treatment assessment from cycle 1 as the maximum number of stools in one 24 hour period during the past 2 weeks. Any incidence of grade 2 or greater diarrhea during treatment or for up to 21 days after the last administration of cabazitaxel will be included in this endpoint.

National Cancer Institute (NCI)

Sanofi

University of Southern California

Skin and Connective Tissue Diseases

Breast Neoplasms

Carcinoma

Carcinoma, Ductal, Breast

Breast Diseases

Skin Diseases

Antirheumatic Agents

Bone Density Conservation Agents

Anticoagulants

Anti-Infective Agents

Other Dietary Supplements

Cyclophosphamide

Tamoxifen

Doxorubicin

Liposomal doxorubicin

Estrogens

Citric Acid

Sodium Citrate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Citrate

cyclophosphamide

doxorubicin hydrochloride

tamoxifen citrate

Richard G. Margolese, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to study the effectiveness of tamoxifen, octreotide, and chemotherapy in treating women who have stage I or stage II breast cancer.

OBJECTIVES: I. Determine whether the addition of octreotide pamoate to tamoxifen alone or to tamoxifen and chemotherapy improves the disease free survival of patients with primary invasive breast cancer with estrogen receptor (ER) positive tumors and histologically negative axillary lymph nodes or histologically negative sentinel lymph nodes if participating in NSABP B-32. II. Determine whether the rate of endometrial cancer associated with tamoxifen is altered by the concurrent administration of octreotide pamoate. III. Determine whether the addition of octreotide pamoate to tamoxifen decreases the rate of opposite breast cancer more than tamoxifen alone. IV. Evaluate the incidence of gallstone formation (including the development of symptoms and complications of biliary tract disease), hyper and hypoglycemia, hypothyroidism, and vitamin B12 deficiency in patients treated with octreotide pamoate in comparison with patients not treated with octreotide pamoate.

OUTLINE: This is a randomized study. Patients are randomized into one of four treatment arms. Arm I: Patients receive oral tamoxifen (TMX) daily continously for 5 years. Lumpectomy patients receive breast radiotherapy following recovery from surgery. Arm II: Patients receive TMX as in Arm I and octreotide pamoate (SMS 201-995 pa LAR) intramuscularly (IM) every 21 days for 4 doses, followed by octreotide pamoate IM for 28 days for 23 additional doses. Lumpectomy patients receive breast radiotherapy following recovery from surgery. Arm III: Patients receive doxorubicin (DOX) IV and cyclophosphamide (CTX) IV every 3 weeks for 4 courses and TMX as in Arm I. Lumpectomy patients receive breast radiotherapy after recovery from chemotherapy. Arm IV: Patients receive DOX and CTX as in Arm III, TMX as in Arm I, and octreotide pamoate as in Arm II. Patients receive TMX and octreotide pamoate on day 1 of first course of chemotherapy. Lumpectomy patients receive breast radiotherapy after recovery from chemotherapy.

PROJECTED ACCRUAL: Total accrual of 3,000 patients will be acrrued for this study over 5 years.

Octreotide, Tamoxifen, and Chemotherapy in Treating Women With Breast Cancer

A Clinical Trial to Evaluate the Benefit of Adding Octreotide (SMS 201-995 PA LAR) to Tamoxifen Alone or to Tamoxifen and Chemotherapy in Patients With Axillary Node-Negative, Estrogen-Receptor-Positive, Primary Invasive Breast Cancer

NSABP Foundation Inc

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel	NCT01469338	Diarrhea Hormone-resista... Recurrent Prost... Stage I Prostat... Stage IIA Prost... Stage IIB Prost... Stage III Prost... Stage IV Prosta...	cabazitaxel prednisone octreotide pamo... questionnaire a... octreotide acet...	18 Years -	University of Southern California
Octreotide, Tamoxifen, and Chemotherapy in Treating Women With Breast Cancer	NCT00002967	Breast Cancer	cyclophosphamid... doxorubicin hyd... octreotide pamo... tamoxifen citra...	-	National Cancer Institute (NCI)
Octreotide, Tamoxifen, and Chemotherapy in Treating Women With Breast Cancer	NCT00002967	Breast Cancer	cyclophosphamid... doxorubicin hyd... octreotide pamo... tamoxifen citra...	-	National Cancer Institute (NCI)
Octreotide, Tamoxifen, and Chemotherapy in Treating Women With Breast Cancer	NCT00002967	Breast Cancer	cyclophosphamid... doxorubicin hyd... octreotide pamo... tamoxifen citra...	-	National Cancer Institute (NCI)
Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel	NCT01469338	Diarrhea Hormone-resista... Recurrent Prost... Stage I Prostat... Stage IIA Prost... Stage IIB Prost... Stage III Prost... Stage IV Prosta...	cabazitaxel prednisone octreotide pamo... questionnaire a... octreotide acet...	18 Years -	University of Southern California
Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel	NCT01469338	Diarrhea Hormone-resista... Recurrent Prost... Stage I Prostat... Stage IIA Prost... Stage IIB Prost... Stage III Prost... Stage IV Prosta...	cabazitaxel prednisone octreotide pamo... questionnaire a... octreotide acet...	18 Years -	University of Southern California

Spots Global Cancer Trial Database for octreotide pamoate