Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer

NCT00003394 | Completed Phase 1

• 3 other identifiers: 98-032CDR0000066392NCI-G98-1448
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting of estramustine, paclitaxel, and carboplatin in treating patients with advanced prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer; recurrent prostate cancer

Interventions

carboplatin DRUG

endocrine-modulating drug therapy DRUG

estramustine phosphate sodium DRUG

goserelin acetate DRUG

leuprolide acetate DRUG

paclitaxel DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven prostate cancer that is androgen dependent or independent Androgen dependent disease must meet ONE OR MORE of the following criteria: (1) Previously untreated, locally advanced adenocarcinoma of the prostate and: T1-2 tumor stage, PSA greater than 20 ng/mL OR T3-4 tumor stage OR Gleason grade 8-10 (2) Small cell carcinoma, poorly differentiated tumor with neuroendocrine features, or neuroendocrine carcinoma of any stage (3) Disease metastatic to bones or soft tissues (visceral or lymph nodes) that is evaluable on MRI, CT, or bone scan (patients with evaluable disease that relapsed after neoadjuvant hormone therapy prior to radical prostatectomy or radiotherapy are eligible) Patients meeting one of the above criteria who have started on an antiandrogen (flutamide, nilutamide, or bicalutamide) and/or a gonadotropin releasing hormone (GnRH) analog (luprolide or goserelin) are eligible if they have been on androgen ablation (GnRH analog with or without antiandrogen) for no more than 3 months Androgen independent disease must meet ALL of the following criteria: (1) Disease progression despite primary hormone treatment (e.g., orchiectomy, estrogen therapy, GnRH analog with or without an antiandrogen), OR disease progression despite receiving antiandrogen treatment as part of primary hormone therapy, evidenced by: Bone (new osseous lesion) or Soft tissue (greater than 25% increase in bidimensionally measurable disease) or Rising PSA (on any 3 determinations taken at weekly intervals (at least) to greater than 50% above the patient's baseline PSA value) despite castrate (no greater than 30 ng/mL) levels of testosterone (2) At least 2 weeks since change in hormone therapy (including prednisone or dexamethasone) (3) Continuation on treatments to maintain castrate levels of testosterone if no prior orchiectomy (4) Evaluable or measurable disease (5) No more than 1 prior course of chemotherapy (6) No more than 1 prior course of palliative radiotherapy or radioisotope treatment (strontium chloride Sr 89) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 120,000/mm3 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL or 1.5 times upper limit of normal (ULN) AST no greater than 56 U/L or 1.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL or 1.5 times ULN Cardiovascular: At least 6 months since acute deep vein thrombosis and/or pulmonary embolism No serious ventricular arrhythmia No significant heart disease No active angina (stable or unstable) No myocardial infarction within 6 months No congestive heart failure No transient ischemic attack or stroke within 6 months Neurologic: No grade 3-4 peripheral neuropathy Other: No severe infection No severe malnutrition No other serious medical illnesses PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since immunotherapy Chemotherapy: See Disease Characteristics At least 4 weeks since chemotherapy No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since radiotherapy (8 weeks if systemic radioisotope treatment with strontium chloride Sr 89) No concurrent radiation of the only measurable lesion No concurrent radiotherapy or radioisotope therapy Surgery: See Disease Characteristics At least 4 weeks since major surgery No concurrent surgery to the only measurable lesion Other: Permanent venous access device (e.g., mediport or Hickman catheter) required

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Carboplatin; Estramustine; Goserelin; Leuprolide; 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)

Coordination Complexes; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes

Study Officials

• William K. Kelly, DO

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 30, 2004
• Study Start: April 1, 1998
• Primary Completion: April 1, 2003
• Study Completion: April 1, 2003
• Last Updated: June 24, 2013

Record last verified: 2013-06

Locations

US (1)