Fallopian Tube CancerPhase 1NCT00045175
UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
A Phase 1 study testing 7-hydroxystaurosporine and topotecan hydrochloride in people with Fallopian Tube Cancer and Ovarian Cancer, run by University Health Network, Toronto at 3 sites in Canada.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Topotecan may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy with topotecan may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- What is being tested?
- 7-hydroxystaurosporine and topotecan hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesCanada
- Study dates
- Jun 2002to Jun 2013
- 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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
- Measurable disease outside of field of prior radiotherapy OR
- Progressive disease within field after radiotherapy
- Must have had no more than 2 prior chemotherapy regimens
- At least 1 prior regimen must have included a platinum agent (e.g., carboplatin or cisplatin)
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- More than 12 weeks
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than upper limit of normal (ULN)
- AST/ALT no greater than 2.5 times ULN
Renal
- Creatinine no greater than ULN OR
- Creatinine clearance at least 50 mL/min
Cardiovascular
- No coronary artery disease
- No symptomatic cardiac dysfunction
- No symptoms suggestive of coronary artery disease with evidence of cardiac pathology
Pulmonary
- No symptomatic pulmonary dysfunction
Other
- No prior allergic reaction attributed to compounds of similar chemical or biologic composition to UCN-01 or other agents used in this study
- No insulin-dependent diabetes mellitus
- No other uncontrolled concurrent illness
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior biologic therapy
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No prior topotecan (other prior topoisomerase I inhibitors allowed)
Endocrine therapy
- At least 4 weeks since prior hormonal therapy
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy to more than 40% of bone marrow
- No prior mediastinal irradiation
Surgery
- At least 4 weeks since prior surgery
Other
- Recovered from all prior therapy
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
- No concurrent combination antiretroviral therapy for HIV-positive patients
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase I Study of UCN-01 in Combination With Topotecan in Patients With Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Topotecan may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy with topotecan may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and recommended phase II dose of UCN-01 and topotecan in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the relationship between clinical and pharmacokinetic effects of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive UCN-01 IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of UCN-01 and topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 12 additional ovarian epithelial cancer patients are then treated at the recommended phase II dose.
Patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 6-10 months.
- Being tested
- 7-hydroxystaurosporine, topotecan hydrochloride
- Keywords
- primary peritoneal cavity cancer, recurrent ovarian epithelial cancer, fallopian tube 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.
7-hydroxystaurosporineDrug
topotecan hydrochlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| UCN-01 in combination with topotecan | Experimental | Not described Receives: Drug: 7-hydroxystaurosporine; Drug: topotecan hydrochloride |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 2002
- Primary completionJun 2013
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 University Health Network, TorontoThe 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hal W. Hirte, MD, FRCP(C), Study chair, Margaret and Charles Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00045175
- Sponsor's protocol ID
- PMH-PHL-005
- Other IDs
- CDR0000256917, NCI-5518
- Status last verified
- Jun 2016
- First submitted
- 6 Sep 2002
- Last updated
- 23 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of UCN-01 in Combination With Topotecan in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00045175
- Acronym / sponsor ID
- PMH-PHL-005
- Keywords
- primary peritoneal cavity cancer, recurrent ovarian epithelial cancer, fallopian tube cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2002
- Primary completion
- Jun 2013 (actual)
- First posted
- 27 Jan 2003 (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 use different ways to stop tumor cells from dividing so they stop growing or die. Topotecan may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy with topotecan may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and recommended phase II dose of UCN-01 and topotecan in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the relationship between clinical and pharmacokinetic effects of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive UCN-01 IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of UCN-01 and topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 12 additional ovarian epithelial cancer patients are then treated at the recommended phase II dose.
Patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 6-10 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UCN-01 in combination with topotecan | Experimental | Drug: 7-hydroxystaurosporine, Drug: topotecan hydrochloride |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| 7-hydroxystaurosporine | Drug | UCN-01 in combination with topotecan |
| topotecan hydrochloride | Drug | UCN-01 in combination with topotecan |
Primary outcome
Not reported in the source record.
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 23 Jun 2016.
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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.
Hal W. Hirte, MD, FRCP(C) study chair
Margaret and Charles Juravinski Cancer Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 7-hydroxystaurosporine and topotecan hydrochloride in people with Fallopian Tube Cancer and Ovarian Cancer, run by University Health Network, Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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.
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 23 Jun 2016.