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Fallopian Tube CancerPhase 2NCT00072267

UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

A Phase 2 study testing 7-hydroxystaurosporine and topotecan hydrochloride in people with Fallopian Tube Cancer and Ovarian Cancer, run by University Health Network, Toronto at 4 sites in Canada.

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: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining UCN-01 with topotecan may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
7-hydroxystaurosporine and topotecan hydrochloride
How many people
Not given
Where
4 sitesCanada
Study dates
Jan 2004to Apr 2005
Phase
Phase 2
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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
  • Progressive, persistent, or recurrent disease
  • Measurable disease outside prior radiotherapy field unless disease progression occurred after radiotherapy
  • Tumor lesions accessible for biopsy
  • Patients with a medical contraindication to tumor biopsy may be allowed at the discretion of the principal investigator
  • No more than 2 prior chemotherapy regimens
  • At least 1 regimen must have contained a platinum agent (i.e., 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 history of coronary artery disease
  • No symptomatic cardiac dysfunction
  • No cardiac pathology by electrocardiogram* NOTE: *Patients with symptomatic coronary artery disease must undergo an electrocardiogram

Pulmonary

  • No symptomatic pulmonary dysfunction

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 8 weeks after study participation
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents
  • No insulin-dependent diabetes mellitus
  • Diabetes controlled by diet or oral hypoglycemic agents allowed at the discretion of the investigator
  • No other concurrent uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior biologic therapy and recovered

Chemotherapy

  • See Disease Characterisitcs
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior topotecan
  • No other prior topoisomerase I inhibitors

Endocrine therapy

  • More than 4 weeks since prior hormonal therapy and recovered

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 40% of bone marrow
  • No prior mediastinal irradiation

Surgery

  • More than 4 weeks since prior surgery and recovered

Other

  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Trial locations and contacts

4 sites in 1 country.

Canada4 sites
  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian Cancer

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining UCN-01 with topotecan may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the antitumor activity of UCN-01 and topotecan, in terms of complete and partial objective response rates, in patients with recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Secondary

  • Determine the antitumor activity of this regimen, in terms of stable disease rates and duration of response, in these patients.
  • Determine the progression-free, median, and overall survival of patients treated with this regimen.
  • Determine the safety and tolerability of this regimen in these patients.
  • Determine the relationship between clinical and pharmacodynamic effects of this regimen in these patients.

OUTLINE: This is a 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 up to 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 5-11 months.

Being tested
7-hydroxystaurosporine, topotecan hydrochloride
Keywords
stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer, stage III 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.

  • 7-hydroxystaurosporineDrug

  • topotecan hydrochlorideDrug

Timeline

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

  1. First posted6 Nov 2003 (estimated)
  2. Study startJan 2004
  3. Primary completionApr 2005

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 2
Primary purpose
Treatment
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00072267
Sponsor's protocol ID
PMH-PHL-019
Other IDs
CDR0000339563, NCI-6402
Status last verified
Jul 2015
First submitted
4 Nov 2003
Last updated
23 Jul 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 7-hydroxystaurosporine and topotecan hydrochloride in people with Fallopian Tube Cancer and Ovarian Cancer, run by University Health Network, Toronto at 4 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 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Jul 2015.

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