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Prostate CancerPhase 1/2NCT00003394

Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer

A Phase 1/2 study testing carboplatin, endocrine-modulating drug therapy and estramustine phosphate sodium in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
carboplatin, endocrine-modulating drug therapy and estramustine phosphate sodium
How many people
18 participants
Where
1 siteUnited States
Study dates
Apr 1998to Apr 2003
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

Official title: Phase I/II Study of Weekly Intravenous Estramustine Phosphate in Combination With Paclitaxel and Carboplatin in Patients With Advanced Prostate Cancer

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.

Read the detailed description

OBJECTIVES: I. Determine a safe weekly dose of intravenous estramustine (EM) in combination with paclitaxel (TAX) and carboplatin (CBDCA) in patients with advanced prostate cancer. II. Determine the safety and efficacy of this combination in androgen dependent vs androgen independent disease in these patients. III. Evaluate the pharmacokinetics of weekly intravenous EM and TAX in combination with CBDCA in these patients.

OUTLINE: Phase I is a dose escalation study of estramustine. Phase II is a two stage design study, in which patients are stratified according to androgen dependence (androgen dependent disease vs androgen independent disease). In phase I, patients receive estramustine IV over 1 hour via permanent venous access device on day 1 of weeks 1, 2, 3, and 4, followed by paclitaxel (TAX) IV over 1 hour. Carboplatin IV is administered over 30 minutes at the completion of TAX at week 1. Courses repeat every 4 weeks until disease progression or excessive toxicity or for up to 24 weeks. Patients with locally advanced androgen dependent prostate cancer may be considered for radical prostatectomy or radiotherapy after 4 courses. Androgen dependent patients not already on primary hormone therapy with a GnRH analog receive goserelin or leuprolide injections under the skin every 3 months while on the study, beginning during the first or second week of therapy. Three patients are entered at each dose level and must complete one course of therapy. If no patient experiences dose limiting toxicity (DLT), then 3 patients are treated at the next higher dose level. If 1 patient experiences DLT, then 3 more patients are treated at that same dose level. If 2 of 6 patients experience DLT, then that dose is declared the maximum tolerated dose (MTD). In phase II, a two stage design is applied to each patient population. Fourteen patients are enrolled in the first stage. If no responses are observed, the trial is stopped. If at least 1 response is observed, 11 additional patients will be enrolled onto the study.

PROJECTED ACCRUAL: A total of 6-18 patients will be accrued to phase I; phase II will accrue up to 50 patients within 3 years.

Conditions
Prostate Cancer
Being tested
carboplatin, endocrine-modulating drug therapy, estramustine phosphate sodium, goserelin acetate, leuprolide acetate
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
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • carboplatinDrug

  • endocrine-modulating drug therapyDrug

  • estramustine phosphate sodiumDrug

  • goserelin acetateDrug

  • leuprolide acetateDrug

  • paclitaxelDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2004 (estimated)
  2. Study startApr 1998
  3. Primary completionApr 2003
  4. Study completionApr 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003394
Sponsor's protocol ID
98-032
Other IDs
CDR0000066392, NCI-G98-1448
Status last verified
Jun 2013
First submitted
1 Nov 1999
Last updated
24 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing carboplatin, endocrine-modulating drug therapy and estramustine phosphate sodium in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.

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