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Recurrent Small-cell Lung Cancer (SCLC)Phase 2NCT00698516

Study of Oral Topotecan With Bevacizumab for Recurrent Small Cell Lung Cancer

A Phase 2 study testing Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab) in people with Recurrent Small-cell Lung Cancer (SCLC) and Lung Cancer, Small Cell, run by GlaxoSmithKline at 16 sites 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

Combination of Hycamtin (topotecan) and Avastin (bevacizumab) could allow killing of both endothelial and neoplastic cells. We postulate that addition of bevacizumab to topotecan will increase delivery of topotecan to tumor cells and may enhance activity of topotecan in patients with previously treated small cell lung… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
16 sitesUnited States
Study dates
Jul 2008to May 2010
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed diagnosis of SCLC.
  • First recurrence of SCLC after therapy with one prior chemotherapy regimen at initial diagnosis.
  • Relapsed SCLC of any duration (both sensitive and resistant relapse).
  • ECOG performance status of </= 2.
  • Adequate bone marrow reserve, hepatic, renal, and cardiovascular function.
  • No prior therapy with bevacizumab or any other VEGF inhibitor or topotecan

Who cannot join

  • Uncontrolled emesis, regardless of etiology.
  • Active uncontrolled infection.
  • GI conditions or drugs that could impact absorption of oral topotecan.
  • Known hypersensitivity to any component of topotecan capsule or compounds chemically related to topotecan.
  • Uncontrolled hypertension with BP>150/100.
  • Prior h/o hypertensive crisis or encephalopathy.
Show all 20Show fewer
  • NYHA Grade II or greater congestive heart failure.
  • H/O myocardial infarction within 6 months.
  • H/O stroke or TIA within 6 months.
  • H/O thrombotic or hemorrhagic disorders.
  • Clinically significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days.
  • Anticipation of need for major surgical procedure during the study.
  • Minor surgical procedures within 7 days prior to treatment start (placement of vascular access devices is permitted).
  • H/O abdominal fistula, GI perforation, or intra-abdominal abscess within prior 6 months. Serious, non-healing wound, active ulcer, or untreated bone fracture. - H/O hemoptysis within prior 1 month.
  • Concurrent radiotherapy.
  • H/O whole lung radiation within 90 days prior to start of treatment.
  • Presence or h/o central nervous system or brain metastases.
  • H/o another malignancy other than SCLC.
  • Concurrent chemotherapy, immunotherapy, or investigational therapy for the treatment of small cell lung cancer.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • GSK Investigational Site

    Athens, Georgia, 30607

  • GSK Investigational Site

    Chattanooga, Tennessee, 37404

  • GSK Investigational Site

    Cincinnati, Ohio, 45236

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Gainesville, Florida, 32605

  • GSK Investigational Site

    Jackson, Mississippi, 39202

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Macon, Georgia, 31201

  • GSK Investigational Site

    Madison, Wisconsin, 53792

  • GSK Investigational Site

    Marietta, Georgia, 30060

  • GSK Investigational Site

    Memphis, Tennessee, 38104

  • GSK Investigational Site

    Memphis, Tennessee, 38120

  • GSK Investigational Site

    Mt. Pleasant, South Carolina, 29464

  • GSK Investigational Site

    Naples, Florida, 34119

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    Seattle, Washington, 98101-2795

Other trials in United States

About this study

Official title: An Open-label, Multicenter, Non-comparative, Phase II Study of Oral Topotecan in Combination With Bevacizumab for Second-line Treatment in Subjects With Relapsed Small-cell Lung Cancer (SCLC)

Combination of Hycamtin (topotecan) and Avastin (bevacizumab) could allow killing of both endothelial and neoplastic cells. We postulate that addition of bevacizumab to topotecan will increase delivery of topotecan to tumor cells and may enhance activity of topotecan in patients with previously treated small cell lung cancer and improve progression free survival.

Being tested
Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab)
Keywords
Bevacizumab, Small Cell Lung Cancer (SCLC), Topotecan
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab)Drug

    2.3 mg/m2 daily x 5 oral topotecan and 15 mg/kg IV bevacizumab on day 1 of every 21 days cycle.

Study groups in NCT00698516
Study groupRoleWhat they receive
Open label, Single armExperimentalOral topotecan + IV Bevacizumab
Receives: Drug: Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab)

What is being measured

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

  1. Percentage of Participants With Progression-free Survival (PFS) at 3 Months

    PFS = time from initiation of drug to time of first disease progression/death due to any cause. Progression assessed using Response Evaluation Criteria (RECIST): >=20% increase in sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or appearance of new lesion(s). If participant did not progress or die, the time of initiation of post-treatment anti-cancer therapy or time of last contact used. PFS at 3 months calculated by taking the Kaplan-Meier (KM) estimate at 90 days from the initiation of treatment. SE = standard error.

    Measured: 3 months

Secondary outcomes (6)

  1. PFS - Overall

    Progression-free survival at any site was defined as the time from initiation of investigational product to the time of first documented disease progression or death due to any cause. Progression was assessed using the RECIST guidelines: >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started, or appearance of new lesion (s). For participants who did not progress or die, the time of initiation of post-treatment anti-cancer therapy or the time of last contact was used.

    Measured: Baseline to disease progression or death (up to 82.4 weeks)

  2. Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)

    Tumor response was determined using the RECIST guidelines.CR, disappearance of all target lesions; PR, >=30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since treatment started; PD, >=20% increase in sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Measured: Baseline to disease progression or death (up to 82.4 weeks)

  3. Number of Participants With a Tumor Response (CR and PR)

    Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: >=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.

    Measured: Baseline to disease progression or death (up to 82.4 weeks)

  4. Duration of Tumor Response (CR and PR)

    Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: >=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. Duration of response is defined as the time from start of response (CR or PR) until progression or death due to any cause. For participants who did not progress or die, the time of initiation of post-treatment anti-cancer therapy or the time of last contact was used.

    Measured: Baseline to disease progression or death (up to 82.4 weeks)

  5. Time to Tumor Response (CR and PR)

    Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: >=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. Time to response is defined as the time from initiation of investigational product to the time of first documented response (CR or PR).

    Measured: Baseline to disease progression or death (up to 82.4 weeks)

  6. Overall Survival

    Overall survival is defined as the time from initiation of investigational product to death due to any cause. For participants who did not die, the time of last contact was used.

    Measured: Baseline to disease progression or death (up to 82.4 weeks)

Timeline

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

  1. First posted17 Jun 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionMay 2010
  4. Study completionMay 2010

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00698516
Sponsor's protocol ID
104864/111127
Status last verified
Mar 2011
First submitted
16 Jun 2008
Last updated
27 Mar 2012
Data monitoring committee
No

Publications

  • Spigel DR, Waterhouse DM, Lane S, Legenne P, Bhatt K. Efficacy and safety of oral topotecan and bevacizumab combination as second-line treatment for relapsed small-cell lung cancer: an open-label multicenter single-arm phase II study. Clin Lung Cancer. 2013 Jul;14(4):356-63. doi: 10.1016/j.cllc.2012.12.003. Epub 2013 Feb 4.

    PubMed 23391616

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab) in people with Recurrent Small-cell Lung Cancer (SCLC) and Lung Cancer, Small Cell, run by GlaxoSmithKline at 16 sites 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?

The sponsor lists 6 inclusion and 20 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 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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?

Yes. Results are posted in the registry (first posted 3 Feb 2011). 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?

Percentage of Participants With Progression-free Survival (PFS) at 3 Months (time frame: 3 months). 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 NCT00698516, 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 Mar 2012.

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