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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00541359

Bortezomib and Topotecan Hydrochloride in Treating Patients With Advanced Solid Tumors

A Phase 1 study testing bortezomib, topotecan hydrochloride and immunohistochemistry staining method in people with Unspecified Adult Solid Tumor, Protocol Specific, run by City of Hope Medical Center at 2 sites 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: 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bortezomib, topotecan hydrochloride and immunohistochemistry staining method
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
2 sitesUnited States
Study dates
3 Mar 2004to 16 Jun 2011
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

  • 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
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  • Life expectancy >= 12 weeks
  • ECOG performance status 0, 1, or 2
  • Subjects with asymptomatic brain metastases are allowed

Who cannot join

  • 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.)
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • City of Hope Medical Center

    Duarte, California, 91010

  • City of Hope Medical Group Inc

    Pasadena, California, 91105

Other trials in United States

About this study

Official title: A Phase I Trial of PS-341 in Combination With Topotecan in Advanced Solid Tumor Malignancies

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the safety and feasibility of combining PS-341 with topotecan in patients with advanced solid tumor malignancies.

II. To define the maximum tolerated dose (MTD) of topotecan when administered in combination with a fixed dose of PS-341 and to described the toxicities at each dose studied.

III. To evaluate the pharmacokinetics of topotecan when given in combination with PS-341 at MTD.

SECONDARY OBJECTIVES:

  1. To perform laboratory correlative studies on patients tissue investigating potential predictors of response.

OUTLINE:

PART I (completed as of 09/06/06; all patients enrolled in study after 09/06/06 are enrolled in part II): Patients receive escalating doses of topotecan hydrochloride IV over 30 minutes on days 1 and 8 followed 6 hours later by bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

PART II: Patients receive bortezomib IV on days 1, 4, 8, and 11 followed 6 hours later by escalating doses of topotecan hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

In both parts of the study, patients who achieve a response may receive additional courses of treatment.

After completion of study treatment, patients are followed periodically.

What participants receive

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

Study groups in NCT00541359
Study groupRoleWhat they receive
Arm IExperimentalPART I (completed as of 09/06/06; all patients enrolled in study after 09/06/06 are enrolled in part II): Patients receive escalating doses of topotecan hydrochloride IV over 30 minutes on days 1 and 8 followed 6 hours later by bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. PART II: Patients receive bortezomib IV on days 1, 4, 8, and 11 followed 6 hours later by escalating doses of topotecan hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. In both parts of the study, patients who achieve a response may receive additional courses of treatment.
Receives: Drug: bortezomib; Drug: topotecan hydrochloride; Other: immunohistochemistry staining method; Other: pharmacological study

What is being measured

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

  1. Toxicity as assessed by NCI CTCAE v3.0

    Measured: 21 days after the end of treatment

Secondary outcomes (4)

  1. Overall survival

    Measured: 1 year from the end of treatment

  2. Progression-free survival

    Measured: 1 year from the end of treatment

  3. Time to progression

    Measured: 1 year from the end of treatment

  4. Levels of NF-kB activation

    Measured: At baseline and completion of treatment

Timeline

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

  1. First posted10 Oct 2007 (estimated)
  2. Study start3 Mar 2004
  3. Primary completion16 Jun 2011
  4. Study completion16 Jun 2011

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00541359
Sponsor's protocol ID
03109
Other IDs
NCI-2009-01598, CDR0000570257
Status last verified
Oct 2026
First submitted
5 Oct 2007
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing bortezomib, topotecan hydrochloride and immunohistochemistry staining method in people with Unspecified Adult Solid Tumor, Protocol Specific, run by City of Hope Medical Center at 2 sites 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 9 inclusion and 11 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Toxicity as assessed by NCI CTCAE v3.0 (time frame: 21 days after the end of treatment). 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 NCT00541359.

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 22 Oct 2026.

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