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Completed

NCT Number: NCT00698516

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

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.

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Key information

Conditions

Recurrent Small-cell Lung Cancer (SCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Lung Cancer, Small Cell Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Jonesboro, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. PFS - Overall

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

    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.

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

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

    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.

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

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

    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.

  4. Duration of Tumor Response (CR and PR)

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

    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.

  5. Time to Tumor Response (CR and PR)

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

    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).

  6. Overall Survival

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

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 17, 2008
Registry last updated
Mar 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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