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Ovarian CancerPhase 2NCT00316173

Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer

A Phase 2 study testing topotecan and CARBOPLATIN in people with Ovarian Cancer and Neoplasms, Ovarian, run by GlaxoSmithKline at 22 sites in 2 countries.

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

This study was designed to find the most effective and safest doses of both HYCAMTIN and CARBOPLATIN that can be given for the treatment of ovarian cancer. This study may allow researchers to determine the effectiveness of combining HYCAMTIN and CARBOPLATIN. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer, Neoplasms, Ovarian
What is being tested?
topotecan and CARBOPLATIN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
22 sitesin 2 countries
Study dates
Mar 2005to Mar 2009
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

  • Subject must have baseline laboratory values as follows:
  • Hemoglobin 9.0 g/dL
  • Neutrophils 1,500/mm3
  • Platelets 100,000/mm3
  • Creatinine 1.5 mg/dL ( 133 mol/l) or creatinine clearance 60 mL/min
  • Serum bilirubin < 2.0 mg/dL (< 35 umol/L)
Show all 16Show fewer
  • SGOT/AST, SGPT/ALT and alkaline phosphatase < 2 times ULN if liver metastases are absent by abdominal CT or MRI or < 5 times ULN if liver metastases are present
  • 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
  • Subject is female 18 years of age with an ECOG Performance Status of 0, 1 or 2
  • Subject has recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer which was histologically confirmed at the time of the primary diagnosis
  • Subject has received one prior platinum-based chemotherapeutic regimen (containing either carboplatin or cisplatin) for the treatment of primary disease. Consolidation chemotherapy is not permitted
  • Subject's disease is considered potentially platinum-sensitive (i.e., have had a platinum-free interval following complete response to carboplatin or cisplatin of greater than 6 months)
  • Subject must have at least one measurable lesion as determined by diagnostic studies including CT or MRI or physical exam. Measurable disease must be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be 20 mm in their longest dimension when measured by conventional techniques, including palpation, plain X-ray, CT and MRI, or 10 mm when measured by spiral CT. Palpable tumor masses that cannot be evaluated radiologically must have 2 diameters 20 mm. An attempt to document lesion size by ultrasound should be undertaken for palpable lesions not visualized on CT (or MRI).
  • The same diagnostic imaging method used to evaluate disease must be used throughout the study to evaluate lesions consistently
  • Stable blood, liver and renal functions.
  • Subjects of child-bearing potential must be practicing adequate contraception (e.g. oral contraceptives, diaphragm plus spermicide, or IUD) for at least 3 months prior to study start. The same contraceptive method should be used throughout the study and continue for at least 4 weeks after the end of the study

Who cannot join

  • Pregnant or lactating.
  • Subject has received more than 1 prior chemotherapy regimen or a history of consolidation cytotoxic chemotherapy
  • 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 5 years
  • Subject has brain metastases as documented by CT or MRI. Note: Asymptomatic subjects do not require CT or MRI to rule out brain metastases
  • Received previous treatment with HYCAMTIN.
  • Subject has received an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to study entry
  • Received prior radiation therapy for ovarian cancer

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

United States18 sites

  • GSK Investigational Site

    Albany, New York, 12208

  • GSK Investigational Site

    Brightwaters, New York, 11718

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599-7570

  • GSK Investigational Site

    Charlotte, North Carolina, 28203

  • GSK Investigational Site

    Cleveland, Ohio, 44109-1998

  • GSK Investigational Site

    Greenville, South Carolina, 29605

  • GSK Investigational Site

    Las Vegas, Nevada, 89109

  • GSK Investigational Site

    Los Angeles, California, 90033

  • GSK Investigational Site

    Mayfield Heights, Ohio, 44124

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53215

  • GSK Investigational Site

    New Haven, Connecticut, 06520

  • GSK Investigational Site

    Orange, California, 92868

  • GSK Investigational Site

    Poway, California, 92064

  • GSK Investigational Site

    Salt Lake City, Utah, 84112-5550

  • GSK Investigational Site

    Savannah, Georgia, 21404

  • GSK Investigational Site

    Seattle, Washington, 98101

  • GSK Investigational Site

    South Bend, Indiana, 46617

  • GSK Investigational Site

    Stanford, California, 94305

Other trials in United States

Canada4 sites

  • GSK Investigational Site

    Calgary, Alberta, T2N 4N2

  • GSK Investigational Site

    Montreal, Quebec, H2L 4M1

  • GSK Investigational Site

    Québec, Quebec, G1R 2J6

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

Official title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer

This study was designed to find the most effective and safest doses of both HYCAMTIN and CARBOPLATIN that can be given for the treatment of ovarian cancer. This study may allow researchers to determine the effectiveness of combining HYCAMTIN and CARBOPLATIN.

Being tested
topotecan, CARBOPLATIN
Keywords
HYCAMTIN, ovarian cancer, recurrent, relapsed, carboplatin, topotecan, potentially platinum-sensitive
Medical subject headings
Ovarian Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • topotecanDrug

    HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1

  • CARBOPLATINDrug

    HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1

Study groups in NCT00316173
Study groupRoleWhat they receive
Single-armExperimentalHYCAMTIN at a dose of 2.0 - 2.5mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1, every 21 days
Receives: Drug: topotecan; Drug: CARBOPLATIN

What is being measured

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

  1. Number of Participants With the Indicated Response

    Overall response rate, as determined by radiologic evaluation (utilizing the World Health Organization [WHO] criteria and/or physical examination was measured. Complete response (CR: complete disappearance of all lesions), partial response (PR: >50% decrease in the measurements of the largest lesions with no appearance of new lesions), stable disease (SD: no change in tumor size for at least 8 weeks) and progressive disease (PD: >25% increase in measurements of lesions or appearance of new lesions).

    Measured: From start of treatment to evidence of CR or PR (up to 39.3 weeks).

Secondary outcomes (6)

  1. Time to Response

    Time to response was calculated as the time from start of treatment until first evidence of partial response (PR; >50% decrease in the measurements of the largest lesions with no appearance of new lesions) or complete response (CR; complete disappearance of all lesions).

    Measured: From start of treatment to evidence of PR or CR (up to 39.3 weeks)

  2. Duration of Response

    Duration of response was calculated as the time from first documented PR or CR until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was "censored".

    Measured: From time of PR or CR to disease progression/death (up to 56.0 weeks)

  3. Progression-free Survival

    Progression-free survival (PFS) was calculated as the time from the start of treatment until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was "censored". Although "Time to Disease Progression" was stated as an endpoint in the protocol, the definition given in the protocol (and used in the study) was that of "PFS". As such, "PFS" was measured, not "Time to Disease Progression".

    Measured: From start of treatment to disease progression/death (up to 67.7 weeks)

  4. Number of Participants Who Died From the Start of Treatment to Follow-up

    The number of participants who died from the start of treatment to follow-up was calculated. For participants who did not die, the date of last contact was used. The word used for such participants was "censored".

    Measured: From start of treatment to death (up to 110.4 weeks).

  5. The Number of Participants Classified as Responders in Cancer Antigen 125 (CA-125)

    CA-125 is a "tumor marker", found in greater concentration in tumor cells than other cells of the body. Participants were classed as responders if their CA-125 level at the end of study was 50% or less of baseline. In addition, a confirmatory sample (taken at least 28 days after the first sample) must have also been 50% or less of baseline.

    Measured: Baseline to end of study (up to 54.7 weeks).

  6. Time to Disease Progression

    Although "Time to Disease Progression" was stated as an endpoint in the protocol, the definition given in the protocol (and used in the study) was that of "Progression-free Survival". As such, "Progression-free Survival" was measured, not "Time to Disease Progression". See the outcome measure entitled "Progression-free Survival" for data pertaining to time to disease progression.

    Measured: From start of treatment to disease progression/death

Timeline

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

  1. First posted20 Apr 2006 (estimated)
  2. Study startMar 2005
  3. Primary completionJan 2009
  4. Study completionMar 2009

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00316173
Sponsor's protocol ID
104864/902
Status last verified
Nov 2012
First submitted
19 Apr 2006
Last updated
27 Nov 2012
Data monitoring committee
Yes

Publications

  • Rose PG, Monk BJ, Provencher D, Hartney J, Legenne P, Lane S. An open-label, single-arm Phase II study of intravenous weekly (Days 1 and 8) topotecan in combination with carboplatin (Day 1) every 21 days as second-line therapy in patients with platinum-sensitive relapsed ovarian cancer. Gynecol Oncol. 2011 Jan;120(1):38-42. doi: 10.1016/j.ygyno.2010.10.011. Epub 2010 Nov 5.

    PubMed 21055798

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing topotecan and CARBOPLATIN in people with Ovarian Cancer and Neoplasms, Ovarian, run by GlaxoSmithKline at 22 sites in 2 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 16 inclusion and 7 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 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, 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?

Yes. Results are posted in the registry (first posted 26 Nov 2009). 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?

Number of Participants With the Indicated Response (time frame: From start of treatment to evidence of CR or PR (up to 39.3 weeks).). 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 NCT00316173, 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 27 Nov 2012.

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