Fallopian Tube CancerPhase 1NCT00287859
Topotecan in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
A Phase 1 study testing topotecan hydrochloride in people with Fallopian Tube Cancer and Ovarian Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy drugs may have different effects in patients who have a poor performance status. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
- What is being tested?
- topotecan hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Dec 2006
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
- Progressive or recurrent disease
- Received ≥ 1 prior course of chemotherapy
- Measurable or evaluable disease OR disease assessable by CA 125, defined as CA 125 > normal that has increased over 2 readings > 14 days apart
- Karnofsky performance status 10-50%
- Absolute neutrophil count ≥ 1,500/mm^3
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- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 1.5 mg/dL
- Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 times ULN
- SGOT ≤ 3 times ULN
- Life expectancy ≥ 12 weeks
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use accepted and effective non-hormonal contraception
Who cannot join
- Other neoplasm within the past 5 years except for nonmetastatic, nonmelanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery or chemotherapy
- Septicemia, severe infection, or acute hepatitis
- Severe gastrointestinal bleeding, defined as requiring a blood transfusion or hospitalization
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
About this study
Official title: Phase I Study of Weekly Topotecan in Women With Progressive or Recurrent Ovarian Cancer and a Poor Performance Status
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy drugs may have different effects in patients who have a poor performance status.
PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in treating patients with progressive or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer with a poor performance status.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of weekly topotecan in patients with progressive or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer and a poor performance status.
Secondary
- Estimate the response rate of women with poor performance status for use in future clinical trials.
OUTLINE: This is a dose-escalation study.
Patients receive topotecan intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan 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. A total of 6 patients will be treated at the MTD.
Patients are followed periodically for up to 2 years.
- Being tested
- topotecan hydrochloride
- Keywords
- fallopian tube cancer, peritoneal cavity cancer, recurrent ovarian epithelial cancer
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topotecan hydrochlorideDrug
Also called Hycamtin(R)
intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29.
| Study group | Role | What they receive |
|---|---|---|
| Escalating Cohorts | Experimental | Patients receive topotecan intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan 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. A total of 6 patients will be treated at the MTD. Receives: Drug: topotecan hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startAug 2004
- Primary completionDec 2006
- Study completionDec 2006
Why it stopped: Withdrawn due to low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Investigators
- Levi S. Downs, MD, Study chair, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287859
- Sponsor's protocol ID
- 2004LS039
- Other IDs
- UMN-WCC-39
- Status last verified
- Nov 2017
- First submitted
- 6 Feb 2006
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Weekly Topotecan in Women With Progressive or Recurrent Ovarian Cancer and a Poor Performance Status
- ClinicalTrials.gov ID
- NCT00287859
- Acronym / sponsor ID
- 2004LS039
- Keywords
- fallopian tube cancer, peritoneal cavity cancer, recurrent ovarian epithelial cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Withdrawn due to low accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 7 Feb 2006 (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.
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy drugs may have different effects in patients who have a poor performance status.
PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in treating patients with progressive or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer with a poor performance status.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of weekly topotecan in patients with progressive or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer and a poor performance status.
Secondary
- Estimate the response rate of women with poor performance status for use in future clinical trials.
OUTLINE: This is a dose-escalation study.
Patients receive topotecan intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan 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. A total of 6 patients will be treated at the MTD.
Patients are followed periodically for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Escalating Cohorts | Experimental | Drug: topotecan hydrochloridePatients receive topotecan intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of topotecan 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. A total of 6 patients will be treated at the MTD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histological diagnosis of ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
- Received ≥ 1 prior course of chemotherapy
- Measurable or evaluable disease OR disease assessable by CA 125, defined as CA 125 > normal that has increased over 2 readings > 14 days apart
- Karnofsky performance status 10-50%
- Absolute neutrophil count ≥ 1,500/mm^3
Key exclusion criteria (3 listed)
- Other neoplasm within the past 5 years except for nonmetastatic, nonmelanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery or chemotherapy
- Septicemia, severe infection, or acute hepatitis
- Severe gastrointestinal bleeding, defined as requiring a blood transfusion or hospitalization
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 |
|---|---|---|
| topotecan hydrochlorideAlso: Hycamtin(R)intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29. | Drug | Escalating Cohorts |
Primary outcome
Maximum tolerated dose
Results and safety
The study was stopped early (reason given: Withdrawn due to low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
Related trials for Fallopian Tube Cancer
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Epithelial Ovarian Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
RecruitingPhase 2
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
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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.
Levi S. Downs, MD study chair
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing topotecan hydrochloride in people with Fallopian Tube Cancer and Ovarian Cancer, run by Masonic Cancer Center, University of Minnesota 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 15 inclusion and 3 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: stopped early, as of the sponsor's last update on 29 Nov 2017. 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 was stopped early (reason given: Withdrawn due to low accrual). Results are not available in the source record.
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. It is what the study was designed to measure, not a finding.
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 29 Nov 2017.