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A phase i trial of PS-341 in combination with topotecan in advanced solid tumor malignancies

NCT ID NCT00541359

Sponsor: City of Hope Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 22, 2026 · Last updated Oct 23, 2026 · Updated 1 time

Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with topotecan hydrochloride may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of topotecan hydrochloride when given together with bortezomib in treating patients with advanced solid tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

54 people

The number who actually took part.

Started

Mar 2004

Finished

Jun 2011

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion * Histologic proof of solid tumor malignancy * ANC \>= 1500/microliter * PLT \>= 150,000/microliter * Total bilirubin =\< 1.5 x upper limit of normal (ULN) * AST =\< 2.5 x ULN or AST =\< 5 x ULN if liver involvement * Serum creatinine =\< 1.5 * Life expectancy \>= 12 weeks * ECOG performance status 0, 1, or 2 * Subjects with asymptomatic brain metastases are allowed Exclusion * ECOG PS 3 or 4 * Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients must not have received chemotherapy or radiation therapy for at least four weeks, and they must have recovered from any toxicities of previous treatment (ongoing grade 1 dermatologic toxicities are allowable) * Eligible patients should not be taking enzyme-inducing anticonvulsants due to the potential of pharmacokinetic interactions * Pregnant and nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\] or abstinence, etc.) * Other concurrent chemotherapy, immunotherapy, or radiotherapy * HIV-positive patients receiving anti-retroviral therapy (HAART); there is a potential for pharmacokinetic interactions * Bisphosphonate therapy (e.g. pamidronate or zoledronate) will not be considered investigational agents for the purpose of trial eligibility * Pre-existing grade \>= 2 neuropathy * No previous treatment with PS-341 allowed, however there is no limit to other prior therapy with chemotherapy, including topotecan, and radiation therapy

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Conditions

The condition(s) this trial relates to.

cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Unspecified adult solid tumor, protocol specific

Contacts and locations

Locations

  • City of Hope Medical Center

    Duarte, California, 91010, United States

  • City of Hope Medical Group Inc

    Pasadena, California, 91105, United States

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