Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00087217

17-N-Allylamino-17-Demethoxygeldanamycin and Paclitaxel in Treating Patients With Metastatic or Unresectable Solid Tumor

A Phase 1 study testing tanespimycin, paclitaxel and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, 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

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Unspecified Adult Solid Tumor, Protocol Specific
What is being tested?: tanespimycin, paclitaxel and laboratory biomarker analysis
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: May 2004to Jun 2008
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 solid malignancy
Metastatic or unresectable disease
Not amenable to standard curative or palliative therapy
No known brain metastases
Performance status - ECOG 0-2
More than 12 weeks

Show all 44Show fewer

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
WBC ≥ 3,000/mm^3
AST and ALT ≤ 2.5 times upper limit of normal
Bilirubin normal
Creatinine normal
Creatinine clearance ≥ 60 mL/min
QTc < 450 msec for male patients (470 msec for female patients)
LVEF > 40% by MUGA
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 New York Heart Association class III or IV congestive heart failure
No poorly controlled angina
No history of uncontrolled dysrhythmia or requirement for antiarrhythmic drugs
No history of congenital long QT syndrome
No active ischemic heart disease within the past year
No left bundle branch block
No other significant cardiac disease
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective double barrier contraception for at least 1 week before, during, and for at least 2 weeks after study participation
No prior allergy to eggs
No prior allergic reaction to compounds of similar chemical or biologic composition to 17-AAG or paclitaxel
No peripheral neuropathy > grade 1
No concurrent uncontrolled illness
No active or ongoing infection
No psychiatric illness or social situation that would preclude study compliance
No concurrent granulocyte colony-stimulating factors
Prior paclitaxel allowed
More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
No prior 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)
More than 4 weeks since prior radiotherapy
No prior radiotherapy that included the heart in the field (e.g., mantle radiotherapy)
No concurrent combination antiretroviral therapy for HIV-positive patients
No concurrent therapeutic-dose warfarin for anticoagulation
No concurrent medications that may prolong QTc interval
No other concurrent investigational agents
No other concurrent anticancer agents or therapies

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Phase I Study of 17- Allylamino-17 Demethoxygeldanamycin (17-AAG) in Combination With Paclitaxel in Advanced Solid Malignancies

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

Read the detailed description

OBJECTIVES:

Determine the maximum tolerated dose and recommended phase II dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) when administered with paclitaxel in patients with metastatic or unresectable solid malignancy.

II. Determine the dose-limiting and non-dose-limiting toxic effects of this regimen in these patients.

III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine tumor response in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG). Patients receive 17-AAG IV over 1 hour on days 1*, 4, 8, 11, 15 and 18 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

NOTE: *17-AAG is not administered on day 1 of course 1. Cohorts of 3-6 patients 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. Once the MTD is determined, 6-12 patients are treated at the recommended phase II dose.

Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Being tested: tanespimycin, paclitaxel, laboratory biomarker analysis, pharmacological study

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
paclitaxelDrug
Also called Anzatax, Asotax, TAX, Taxol
Given IV
laboratory biomarker analysisOther
Correlative studies
pharmacological studyOther
Also called pharmacological studies
Correlative studies

Study groups in NCT00087217
Study group	Role	What they receive
Treatment (tanespimycin, paclitaxel)	Experimental	Patients receive 17-AAG IV over 1 hour on days 1*, 4, 8, 11, 15 and 18 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: tanespimycin; Drug: paclitaxel; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

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

Phase 2 recommended doses of tanespimycin
Tabulated according to the NCI CTC.
Measured: 28 days

Timeline

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

May 2004Jun 2008

First posted12 Jul 2004 (estimated)
Study startMay 2004
Primary completionJun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00087217
Sponsor's protocol ID: NCI-2012-02610
Other IDs: PCI-03-152, U01CA099168, U01CA062502, CDR0000373824
Status last verified: Jan 2013
First submitted: 8 Jul 2004
Last updated: 25 Jan 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Unspecified Adult Solid Tumor, Protocol Specific trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Study of 17- Allylamino-17 Demethoxygeldanamycin (17-AAG) in Combination With Paclitaxel in Advanced Solid Malignancies
ClinicalTrials.gov ID: NCT00087217
Acronym / sponsor ID: NCI-2012-02610
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: May 2004
Primary completion: Jun 2008 (actual)
First posted: 12 Jul 2004 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

Determine the maximum tolerated dose and recommended phase II dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) when administered with paclitaxel in patients with metastatic or unresectable solid malignancy.

II. Determine the dose-limiting and non-dose-limiting toxic effects of this regimen in these patients.

III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine tumor response in patients treated with this regimen.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (tanespimycin, paclitaxel)	Experimental	Drug: tanespimycin, Drug: paclitaxel, Other: laboratory biomarker analysis, Other: pharmacological studyPatients receive 17-AAG IV over 1 hour on days 1*, 4, 8, 11, 15 and 18 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (44 listed)

Histologically confirmed solid malignancy
Not amenable to standard curative or palliative therapy
No known brain metastases
Performance status - ECOG 0-2
More than 12 weeks

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tanespimycinAlso: 17-AAGGiven IV	Drug	Treatment (tanespimycin, paclitaxel)
paclitaxelAlso: Anzatax, Asotax, TAX, TaxolGiven IV	Drug	Treatment (tanespimycin, paclitaxel)
laboratory biomarker analysisCorrelative studies	Other	Treatment (tanespimycin, paclitaxel)
pharmacological studyAlso: pharmacological studiesCorrelative studies	Other	Treatment (tanespimycin, paclitaxel)

Primary outcome

Phase 2 recommended doses of tanespimycin
Time frame: 28 days
Tabulated according to the NCI CTC.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.

Related trials for Unspecified Adult Solid Tumor, Protocol Specific

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RNR Inhibitor COH29 in Treating Patients With Solid Tumors That Are Refractory to Standard Therapy or For Which No Standard Therapy Exists
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Active, not recruiting
Assessment Tool for Older Patients With Cancer
Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment
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Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
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Recruiting
Copenhagen Prospective Personalized Oncology (CoPPO)
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Suresh Ramalingam principal investigator

University of Pennsylvania Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 44 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 25 Jan 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 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?

Phase 2 recommended doses of tanespimycin (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 NCT00087217.

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 25 Jan 2013.