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Neoplasms, EndometrialPhase 2NCT00267488

Intravenous Weekly Topotecan In Subjects With Recurrent Or Persistent Endometrial Cancer

A Phase 2 study testing topotecan in people with Neoplasms, Endometrial and Endometrial Cancer, run by GlaxoSmithKline at 24 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to find out if Hycamtin given weekly is safe and effective for treating your endometrial cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Neoplasms, Endometrial, Endometrial Cancer
What is being tested?
topotecan
How many people
70 participants
Where
24 sitesin 3 countries
Study dates
Oct 2005to Dec 2007
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • A subject will be eligible for inclusion in this study only if all of the following criteria are met:
  • Subject has provided a written informed consent.
  • Subject must be female and ≥18 years of age.
  • Subjects' original endometrial carcinoma (any histologic type) must have had pathologic confirmation.
  • Subject must have recurrent or persistent endometrial cancer.
  • Subject must have at least one measurable lesion according to GOG-modified RECIST criteria.
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  • Measurable disease must be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpation, plain X-ray, CT and MRI, or ≥10 mm when measured by spiral CT.
  • Measurable disease found on chest X-ray must be confirmed with CT or MRI. Either CT or MRI must be used throughout the study to further evaluate these lesions.
  • The same diagnostic method (CT, MRI, X-ray or physical exam) used to evaluate disease, must be used throughout the study to consistently evaluate lesions.
  • Palpable tumor masses that cannot be evaluated by CT or MRI scan should be evaluated by ultrasound or confirmed by biopsy.
  • Evaluable disease (measurable or non-measurable) may be in a field of prior radiation provided that at least six weeks have elapsed since receiving radiation and disease progression is clearly documented by radiographic study. It is preferential for the target lesion to be located outside an irradiated field.
  • Non-measurable disease is defined as all other lesions, including small lesions (longest diameter <20 mm with conventional techniques or <10 mm with spiral CT scan).
  • Subject has received one prior chemotherapy regimen (excluding all topoisomerase I inhibitors e.g., HYCAMTIN and irinotecan).
  • Subject is allowed to have received, but is not required to have received, one additional prior non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition: Non-cytotoxic (biologic or cytostatic) agents include, but are not limited to, monoclonal antibodies, cytokines, and small molecule inhibitors of signal transduction. UM2004/00031/00 CONFIDENTIAL HCT100414 20
  • Subject is at least 21 days from prior chemotherapy and at least 30 days from prior non-cytotoxic therapy and is recovered from associated toxicities.
  • Subject must not have received radiotherapy for at least seven days.
  • Subject must be at least three weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the subject). Subject must have an ECOG Performance Status of 0 or 1 (refer to
  • Appendix 4, ECOG Performance Status).
  • Subject must have, at screening, a probable life expectancy of at least three months.
  • Subject of childbearing potential must be practicing adequate contraception [e.g., oral contraceptives, diaphragm plus spermicide, or intrauterine device (IUD)] or show documented complete abstinence from intercourse for at least three months prior to study start. The same contraceptive method should be used throughout the study and continue for at least four weeks after the end of the study. A subject will be considered of childbearing potential if not surgically sterile or post-menopausal (i.e., documented absence of menses for one year prior to entry into the study).
  • 14. Subject must have screening laboratory criteria as follows:
  • Hemoglobin ≥ 9.0 g/dL.
  • Neutrophils ≥ 1,500/mm³ [≥1.5 x 10^9/L].
  • Platelets ≥ 100,000/mm³ [≥100.0 x 10^9/L].
  • Creatinine ≤ upper limit of normal (ULN) or creatinine clearance (Clcreat) ≥ 60mL/min.
  • Creatinine clearance should be calculated using the Cockcroft-Gault formula:
  • Clcreat (mL/min) = (140-age [yr] x body wt [kg] x 0.85 72 x serum creatinine [mg/dL] OR Clcreat (mL/min) = 1.05 x (140-age [yr] x body wt [kg] serum creatinine [μmol/L]
  • Serum bilirubin within normal limits.
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase < 2xULN if liver metastases are absent by abdominal CT or MRI or < 5xULN if liver metastases are present.

Who cannot join

  • A subject will not be eligible for inclusion in this study if any of the following criteria are met:
  • Subject is pregnant or lactating.
  • Subject has received more than one prior chemotherapy regimen. UM2004/00031/00 CONFIDENTIAL HCT100414 21
  • Subject has concomitant or history of previous malignancies, with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease-free for five years.
  • Subject has active uncontrolled infection.
  • Subject has brain metastases as documented by CT or MRI. Note: Asymptomatic subjects do not require CT or MRI to rule out brain metastases.
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  • Subject has received prior treatment with HYCAMTIN.
  • Subject has a history of an allergic reaction to compounds chemically-related to HYCAMTIN or its constituents.
  • Subject has received any investigational agent within 30 days or five half-lives (whichever is longer) prior to study entry.

Trial locations and contacts

24 sites in 3 countries.

24 sites in 3 countries

United States19 sites

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Chattanooga, Tennessee, 37403

  • GSK Investigational Site

    Chicago, Illinois, 60612

  • GSK Investigational Site

    Columbia, South Carolina, 29210

  • GSK Investigational Site

    Coral Gables, Florida, 33146

  • GSK Investigational Site

    Engelwood, Colorado, 80113

  • GSK Investigational Site

    Greenville, South Carolina, 29605

  • GSK Investigational Site

    Hinsdale, Illinois, 60521

  • GSK Investigational Site

    Knoxville, Tennessee, 37917

  • GSK Investigational Site

    La Jolla, California, 92037

  • GSK Investigational Site

    Lakeland, Florida, 33805

  • GSK Investigational Site

    Lincoln, Nebraska, 68510

  • GSK Investigational Site

    Los Angeles, California, 90033

  • GSK Investigational Site

    Miami, Florida, 33143

  • GSK Investigational Site

    Minneapolis, Minnesota, 55455

  • GSK Investigational Site

    New Orleans, Louisiana, 70115

  • GSK Investigational Site

    Newport Beach, California, 92663

  • GSK Investigational Site

    Orlando, Florida, 32804

  • GSK Investigational Site

    Seattle, Washington, 98104

Other trials in United States

Canada4 sites

  • GSK Investigational Site

    Calgary, Alberta, T2N 4N2

  • GSK Investigational Site

    Montreal, Quebec, H2L 4M1

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

  • GSK Investigational Site

    Québec, Quebec, G1R 2J6

Other trials in Canada

Hungary1 site

  • GSK Investigational Site

    Debrecen, 4032

Other trials in Hungary

About this study

Official title: An Open-label, Phase II, Multicenter Study of Intravenous Weekly Topotecan in Subjects With Recurrent or Persistent Endometrial Cancer

The purpose of this study is to find out if Hycamtin given weekly is safe and effective for treating your endometrial cancer.

Being tested
topotecan
Keywords
Hycamtin, endometrial cancer, topotecan
Medical subject headings
Endometrial Neoplasms

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. Best Overall Response

    Tumor response based on GOG (Gynecological Oncology Group) modified RECIST (Response Evaluation Criteria In Solid Tumors) criteria. A 4-point scale used specifying tumor response. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions; (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; (PD): At least a 20% increase in the sum of the LD of target lesions

    Measured: Week 0 to Week 98 when endpoints were met

Secondary outcomes (5)

  1. Time to Progression

    Kaplan-Meier Estimate. Time to progression is defined as time from start of treatment until the first documented sign of disease progression or death due to progressive disease. Subjects who have not progressed or died at the time of analysis will be censored at the time of initiation of alternative anti-cancer therapy or time of last contact. Percentiles represent a set of points on a scale arrived at by dividing a group into parts in order of magnitude.

    Measured: Week 0 to Week 19 when endpoints were met

  2. Overall Survival

    Kaplan-Meier Estimate. Overall survival is defined as time from start of treatment until death due to any cause. Subjects who are alive at the time of analysis will be censored at the time of last contact.

    Measured: Week 0 to Week 98

  3. Response Duration

    The time from initial documented response to the first documented sign of progression or death due to progressive disease. Not calculated due to no Complete response and only 1 partial response.

    Measured: Week 0 to week 98

  4. Time to Response

    The time from start of treatment until the first documented response. Not calculated due to no Complete response and only 1 partial response.

    Measured: Week 0 to week 98

  5. Safety and Tolerability as Summarized Through Adverse Event Reporting

    AE = Adverse Event reported at a frequency of greater than or equal to 16%. SAE = Serious Adverse Events where all were reported at 0% frequency.

    Measured: Week 0 to week 98

Timeline

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

  1. First posted21 Dec 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionDec 2007
  4. Study completionDec 2007

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
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00267488
Sponsor's protocol ID
100414
Status last verified
Jun 2012
First submitted
20 Dec 2005
Last updated
11 Jul 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing topotecan in people with Neoplasms, Endometrial and Endometrial Cancer, run by GlaxoSmithKline at 24 sites in 3 countries.

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 29 inclusion and 9 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 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Canada, Hungary. 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?

Yes. Results are posted in the registry (first posted 28 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Best Overall Response (time frame: Week 0 to Week 98 when endpoints were met). 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 NCT00267488.

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 11 Jul 2012.

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