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Fallopian Tube CancerPhase 2NCT00217555

Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

A Phase 2 study testing gemcitabine hydrochloride and topotecan hydrochloride in people with Fallopian Tube Cancer and Ovarian Cancer, run by Fred Hutchinson Cancer Center at 1 site 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: Drugs used in chemotherapy, such as gemcitabine and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) 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?
gemcitabine hydrochloride and topotecan hydrochloride
How many people
Not given
Where
1 siteUnited States
Study dates
Jul 2002to Feb 2006
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:

  • Diagnosis of ovarian, fallopian tube, or primary peritoneal cavity cancer
  • Recurrent or persistent platinum-refractory disease, as defined by 1 of the following:
  • Progressive disease while on a platinum compound
  • Persistent clinically measurable disease with best response as stable disease at the completion of ≥ 6 courses of therapy
  • Recurrent disease within 6 months after completion of therapy
  • Measurable or evaluable disease
  • Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests)
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI, OR ≥ 10 mm by spiral CT scan

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-3

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance > 50 mL/min

Other

  • No clinically significant infection
  • No other severe medical condition that would preclude study treatment
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • Prior gemcitabine or topotecan allowed provided disease is not refractory to either drug
  • At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 3 weeks since prior radiotherapy and recovered

Surgery

  • Recovered from recent prior surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Washington School of Medicine

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: Phase II Trial for the Treatment of Recurrent or Persistent Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer With Gemcitabine and Topotecan

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with topotecan works in treating patients with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cavity cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the nature and degree of toxicity of gemcitabine and topotecan in patients with recurrent or persistent platinum-refractory ovarian, fallopian tube, or primary peritoneal cavity cancer.
  • Determine the response rate in patients treated with this regimen.
  • Determine the quality of life of patients treated with this regimen.

Secondary

  • Determine the duration of progression-free survival and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes and topotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond documentation of CR.

Quality of life is assessed at baseline, on day 1 of courses 2, 4, and 6, and then at 1 year.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 36-45 patients will be accrued for this study within 3 years.

Being tested
gemcitabine hydrochloride, topotecan hydrochloride
Keywords
recurrent ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity 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.

What is being measured

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

  1. Toxicity

  2. Response rate

  3. Quality of life

Secondary outcomes (2)

  1. Progression-free survival

  2. Overall survival

Timeline

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

  1. First posted22 Sep 2005 (estimated)
  2. Study startJul 2002
  3. Primary completionFeb 2006

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
NCT00217555
Sponsor's protocol ID
PSOC 1901
Other IDs
PSOC-1901, GSK-PSOC-1901, PSOC-IRB-5320, LILLY-PSOC-1901, CDR0000441309
Status last verified
Sep 2010
First submitted
20 Sep 2005
Last updated
21 Sep 2010
Results posted
No

Publications

  • Goff BA, Holmberg LA, Veljovich D, Kurland BF; Puget Sound Oncology Consortium. Treatment of recurrent or persistent platinum-refractory ovarian, fallopian tube or primary peritoneal cancer with gemcitabine and topotecan: a phase II trial of the Puget Sound Oncology Consortium. Gynecol Oncol. 2008 Aug;110(2):146-51. doi: 10.1016/j.ygyno.2008.04.037. Epub 2008 Jun 6.

    PubMed 18538834

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride and topotecan hydrochloride in people with Fallopian Tube Cancer and Ovarian Cancer, run by Fred Hutchinson Cancer Center 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?

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 21 Sep 2010. 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 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.

What does the primary outcome measure?

Toxicity. The study lists 3 primary outcomes in all. 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 NCT00217555, which also lists 1 linked publication.

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 21 Sep 2010.

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