AzTrials
AzTrials

Recurrent Prostate CancerPhase 1NCT00058253

Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors

A Phase 1 study testing tanespimycin and docetaxel in people with Recurrent Prostate Cancer and Stage IV Prostate Cancer, run by National Cancer Institute (NCI) 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
Search all trials

Trial summary

This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as docetaxel and 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop tumor cells from dividing so they stop… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
tanespimycin and docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
Feb 2003to Mar 2010
Phase
Phase 1
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed metastatic or unresectable malignancy for which standard curative or palliative therapy does not exist or is no longer effective
  • Progressive disease manifested by the following parameters
  • For prostate cancer:
  • Must have castrate, metastatic disease defined by disease progression after surgical castration or treatment with a gonadotropin-releasing hormone (GnRH) analog (testosterone level less than 50 ng/mL)
  • Patients who have not undergone surgical orchiectomy should continue on medical therapies to maintain castrate levels of testosterone
  • Progressive metastatic disease on imaging studies (bone scan, CT scan, or MRI) OR metastatic disease and a rising prostate-specific antigen (PSA)
Show all 96Show fewer
  • Biochemical progression indicated by at least 3 rising PSA values (obtained at least 1 week apart) from a baseline OR 2 rising PSA values (more than 1 month apart), where the percentage increase over the range of values is at least 25%
  • Patients who have received an antiandrogen as part of first-line hormonal therapy must have shown progression of disease off of the antiandrogen prior to study enrollment
  • For other solid tumors:
  • Development of new lesions or an increase in pre-existing lesions by bone scintigraphy, CT scan, MRI, positron emission tomography, or physical examination
  • Patients whose sole criterion for progression is an increase in a biochemical marker (e.g., carcinoembryonic antigen or CA 15-3) or an increase in symptoms are not eligible
  • Patients with metastatic disease must not be progressing to the extent as to require palliative treatment within 4 weeks of study entry
  • No active brain metastases
  • Performance status - Karnofsky 70-100%
  • More than 6 months
  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT < 1.5 times ULN
  • PT ≤ 1.1 times ULN
  • Creatinine no greater than 1.4 mg/dL or within ULN
  • Creatinine clearance greater than 55 mL/min
  • No prior history of pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine)
  • No dyspnea ≥ grade 2 at rest on room air
  • No requirement for supplementary oxygen therapy or oxygen saturations ≤ 88%
  • No clinically significant pulmonary comorbidities that require medication (e.g., severe chronic obstructive pulmonary disease that could predispose patient to pulmonary toxicity)
  • QTc ≤ 450 msec for male patients (470 for female patients)
  • LVEF > 40% by echocardiogram or MUGA
  • Echocardiogram or MUGA required for patients with any of the following:
  • Myocardial infarction > 1 year ago
  • NYHA class I or II CHF
  • Atrial fibrillation
  • Right or left bundle branch block by EKG
  • No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
  • No myocardial infarction within the past year
  • No active ischemic heart disease within the past year
  • No New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)
  • No poorly controlled angina
  • No uncontrolled dysrhythmia
  • No congenital long QT syndrome
  • No left bundle branch block
  • No other significant cardiac disease
  • No prior history of cardiac toxicity after receiving anthracyclines such as doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of severe hypersensitivity reaction to paclitaxel, docetaxel, or polysorbate 80
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No grade 2 or greater symptomatic peripheral neuropathy
  • No allergy to eggs or egg products
  • No other concurrent uncontrolled illness
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy to sole measurable lesion
  • No prior mantle-field radiotherapy
  • See Disease Characteristics
  • No concurrent surgery for sole measurable lesion
  • Recovered from prior therapy
  • At least 1 week since prior ketoconazole and recovered
  • At least 4 weeks since prior investigational anticancer therapeutic drugs
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent medications that prolong QTc interval
  • No concurrent medication used to control arrhythmias
  • Calcium blockers and beta blockers allowed
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies (investigational or commercial)
  • No concurrent CYP3A4 inhibitors, including any of the following:
  • Fluconazole
  • Itraconazole
  • Ketoconazole
  • Macrolide antibiotics (azithromycin, clarithromycin, erythromycin, or troleandomycin)
  • Nifedipine
  • Verapamil
  • Diltiazem
  • Cyclosporine
  • Grapefruit juice
  • No concurrent CYP3A4 inducers, including any of the following:
  • Carbamazepine
  • Phenobarbital
  • Phenytoin
  • Rifampin
  • No concurrent herbal extracts or tinctures with CYP3A4 inhibitory activity, including any of the following:
  • Hydrastis canadensis (goldenseal)
  • Hypericum perforatum (St. John's wort)
  • Uncaria tomentosa (cat's claw)
  • Echinacea angustifolia roots
  • Trifolium pratense (wild cherry)
  • Matricaria chamomilla (chamomile)
  • Glycyrrhiza glabra (licorice)
  • Dillapiol
  • Hypericin
  • Naringenin
  • Concurrent CYP3A4 substrates allowed

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase I Study of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG, NSC# 330507) in Combination With Docetaxel in Patients With Advanced Solid Tumors

This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as docetaxel and 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

Read the detailed description

OBJECTIVES:

  1. Determine the maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) administered with docetaxel in patients with progressive metastatic prostate cancer or other progressive metastatic or unresectable solid tumors.

II. Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG). Patients are assigned to 1 of 2 treatment groups.

Group 1: Patients receive docetaxel IV over 1 hour and 17-AAG IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group 2: Patients receive docetaxel IV over 30 minutes and 17-AAG as in group 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients per group receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 20 additional patients (10 per group) are treated at the MTD.

Patients are followed every 2-3 months.

Being tested
tanespimycin, docetaxel
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • tanespimycinDrug

    Also called 17-AAG

    Given IV

  • docetaxelDrug

    Also called RP 56976, Taxotere, TXT

    Given IV

Study groups in NCT00058253
Study groupRoleWhat they receive
Group IExperimentalPatients receive docetaxel IV over 1 hour and 17-AAG IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: tanespimycin; Drug: docetaxel
Group IIExperimentalPatients receive docetaxel IV over 30 minutes and 17-AAG as in group 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: tanespimycin; Drug: docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose determined by dose-limiting toxicities assessed using the NCI Common Toxicity Criteria (CTC) version 2.0

    Measured: 28 days

Timeline

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

  1. First posted9 Apr 2003 (estimated)
  2. Study startFeb 2003
  3. Primary completionJan 2008
  4. Study completionMar 2010

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00058253
Sponsor's protocol ID
NCI-2012-01436
Other IDs
NCI-2012-01436, NCI-5878, CDR0000287199, MSKCC-03006, 03-006, 5878, P30CA008748, U01CA069856
Status last verified
Dec 2012
First submitted
7 Apr 2003
Last updated
17 Jun 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing tanespimycin and docetaxel in people with Recurrent Prostate Cancer and Stage IV Prostate Cancer, run by National Cancer Institute (NCI) 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?

The sponsor lists 96 inclusion and 0 exclusion criteria. 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 17 Jun 2014. 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 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.

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.

What does the primary outcome measure?

Maximum tolerated dose determined by dose-limiting toxicities assessed using the NCI Common Toxicity Criteria (CTC) version 2.0 (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00058253.

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 17 Jun 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in