Lung CancerPhase 2NCT00365547
Topotecan and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Did Not Respond to Previous Systemic Chemotherapy
A Phase 2 study testing bevacizumab and topotecan hydrochloride in people with Lung Cancer, run by Masonic Cancer Center, University of Minnesota at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as Avastin (bevacizumab), can block tumor growth in different ways. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- bevacizumab and topotecan hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to Sep 2011
- 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
- Patients must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC). Patients with extrathoracic-only squamous cell NSCLC are eligible. Intrathoracic squamous cell carcinoma will not be eligible. Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible.
- Disease that has failed one or more prior standard therapy and is no longer likely to respond to such therapy.
- Prior systemic chemotherapy, immunotherapy, or biological therapy is allowed, except for prior use of Avastin and topotecan in combination. Patient must be at least 14 days from previous radiation or systemic therapy (at least 30 days for investigational agents) and have recovered from the acute toxic effects of the treatment prior to study enrollment.
- Disease status must be measurable or evaluable as defined by Response Evaluation Criteria In Solid Tumors (RECIST criteria)
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
- Age 18 years or greater
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- Adequate organ function within 14 days of study registration including the following:
- Adequate bone marrow reserve:
- absolute neutrophil count (ANC) > or = to 1.5 x 10^9/L,
- platelets >100 x 10^9/L,
- hemoglobin > 9 g/dL
- Hepatic:
- bilirubin <1.5 times the upper limit of normal (x ULN),
- alkaline phosphatase (ALP), aspartate transaminase (AST) and alanine transaminase (ALT) <3.0 x ULN (ALP, AST, and ALT <5 x ULN is acceptable if liver has tumor involvement)
- Renal:
- serum creatinine < 2.0
- urine dipstick for proteinuria < 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible)
- Coagulation:
- International Normalized Ratio (INR) < 1.5
- Partial thromboplastin time (PTT) < the upper limits of normal (ULN)
- Women of childbearing potential and sexually active males are required to use an effective method of contraception (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 3 months after the last dose of study drug.
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Who cannot join
- Pregnant (positive pregnancy test) or breast-feeding. Topotecan is pregnancy category D - clear evidence of risk in pregnancy; Avastin is pregnancy category C - risk in pregnancy cannot be ruled out. Pregnancy testing is not required for post-menopausal or surgically sterilized women
- Known hypersensitivity to any component of Avastin (bevacizumab)
- Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg)
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to Day 1
Show all 17Show fewer
- History of stroke or transient ischemic attack within 6 months prior to Day 1
- Known central nervous system (CNS) disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded
- Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
- History of hemoptysis (≥ ½ teaspoon of bright red blood per episode) within 1 month prior to Day 1
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Active malignancy other than non-small cell lung cancer (NSCLC), treated superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within last five years are allowed.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Inability to comply with study and/or follow-up procedures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, 55416
About this study
Official title: Phase II Clinical Study of Weekly Topotecan in Combination With Avastin™ in Patients With Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Failed Prior Systemic Chemotherapy
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as Avastin (bevacizumab), can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving topotecan together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving topotecan together with bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer that did not respond to previous systemic chemotherapy.
Read the detailed description
OBJECTIVES:
Primary
- Determine the progression-free survival of patients with stage IIIB or IV non-small cell lung cancer treated with topotecan hydrochloride and bevacizumab who have failed prior systemic chemotherapy.
Secondary
- Determine the objective response rates in patients treated with this regimen.
- Measure time-to-event efficacy variables, including time to objective tumor response (for responding patients), duration of response (for responding patients), time to treatment failure, and overall survival.
- Characterize the quantitative and qualitative toxicities of this regimen in these patients.
OUTLINE: Patients receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1, 8, and 15 and Avastin (bevacizumab) IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 6 months from registration.
- Conditions
- Lung Cancer
- Being tested
- bevacizumab, topotecan hydrochloride
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabBiological
Also called Avastin
Will be given by intravenous (IV) infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration until disease progression or for another reason.
topotecan hydrochlorideDrug
Also called Hycamtin(TM)
Topotecan 4 mg/m^2 intravenously (IV) will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22. Treatment will be repeated every 28 days until disease progression or for another reason.
| Study group | Role | What they receive |
|---|---|---|
| Patients Treated With Topotecan and Avastin in NSCLC | Experimental | Weekly topotecan hydrochloride and bi-weekly Avastin (bevacizumab) in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy. Receives: Biological: bevacizumab; Drug: topotecan hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Time to Disease Progression
Assessed by Response Evaluation Criteria In Solid Tumor (RECIST criteria). Progression is defined as a measureable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions since baseline.
Measured: From Day 1 Until First Documented Disease Progression or Date of Death (Whichever Occurred First)
Secondary outcomes (4)
Number of Tumor Responders
Patients that met Solid Tumor Response Criteria (RECIST) criteria for partial response (at least a 30% decrease in the sum of the longest diameters of target lesions) and complete response (disappearance of all target lesions).
Measured: From Day 1 Until Disease Progression or Date of Death (Whichever Occurred First), Up to 1 Year
Median Time to Response
Defined as the time from the start of treatment until first documented evidence of at least a partial tumor response.
Measured: From Day 1 Until Tumor Response
Median Duration of Response
Defined to be the time from first documented evidence of response until the first documented sign of disease progression or death due to progressive disease. For subjects who do not progress or die, duration of response will be censored at the time of last contact.
Measured: Day of 1st Response Until Disease Progression of Death/Last Contact
Median Overall Survival
Defined as the time from the start of treatment until death due to whatever cause. For subjects alive at study completion, time to death will be censored at the time of last contact.
Measured: From Day 1 Until Death Occurred
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arkadiusz Dudek, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365547
- Sponsor's protocol ID
- 2005LS083
- Other IDs
- UMN-0602M81427
- Status last verified
- Dec 2017
- First submitted
- 16 Aug 2006
- Last updated
- 28 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Weekly Topotecan in Combination With Avastin™ in Patients With Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Failed Prior Systemic Chemotherapy
- ClinicalTrials.gov ID
- NCT00365547
- Acronym / sponsor ID
- 2005LS083
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 17 Aug 2006 (estimated)
- Results
- Posted 15 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as Avastin (bevacizumab), can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving topotecan together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving topotecan together with bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer that did not respond to previous systemic chemotherapy.
Detailed description
OBJECTIVES:
Primary
- Determine the progression-free survival of patients with stage IIIB or IV non-small cell lung cancer treated with topotecan hydrochloride and bevacizumab who have failed prior systemic chemotherapy.
Secondary
- Determine the objective response rates in patients treated with this regimen.
- Measure time-to-event efficacy variables, including time to objective tumor response (for responding patients), duration of response (for responding patients), time to treatment failure, and overall survival.
- Characterize the quantitative and qualitative toxicities of this regimen in these patients.
OUTLINE: Patients receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1, 8, and 15 and Avastin (bevacizumab) IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 6 months from registration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Treated With Topotecan and Avastin in NSCLC | Experimental | Biological: bevacizumab, Drug: topotecan hydrochlorideWeekly topotecan hydrochloride and bi-weekly Avastin (bevacizumab) in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC). Patients with extrathoracic-only squamous cell NSCLC are eligible. Intrathoracic squamous cell carcinoma will not be eligible. Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible.
- Disease that has failed one or more prior standard therapy and is no longer likely to respond to such therapy.
- Prior systemic chemotherapy, immunotherapy, or biological therapy is allowed, except for prior use of Avastin and topotecan in combination. Patient must be at least 14 days from previous radiation or systemic therapy (at least 30 days for investigational agents) and have recovered from the acute toxic effects of the treatment prior to study enrollment.
- Disease status must be measurable or evaluable as defined by Response Evaluation Criteria In Solid Tumors (RECIST criteria)
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
Key exclusion criteria (17 listed)
- Pregnant (positive pregnancy test) or breast-feeding. Topotecan is pregnancy category D - clear evidence of risk in pregnancy; Avastin is pregnancy category C - risk in pregnancy cannot be ruled out. Pregnancy testing is not required for post-menopausal or surgically sterilized women
- Known hypersensitivity to any component of Avastin (bevacizumab)
- Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg)
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumabAlso: AvastinWill be given by intravenous (IV) infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration until disease progression or for another reason. | Biological | Patients Treated With Topotecan and Avastin in NSCLC |
| topotecan hydrochlorideAlso: Hycamtin(TM)Topotecan 4 mg/m^2 intravenously (IV) will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22. Treatment will be repeated every 28 days until disease progression or for another reason. | Drug | Patients Treated With Topotecan and Avastin in NSCLC |
Primary outcome
Median Time to Disease Progression
Time frame: From Day 1 Until First Documented Disease Progression or Date of Death (Whichever Occurred First)
Assessed by Response Evaluation Criteria In Solid Tumor (RECIST criteria). Progression is defined as a measureable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions since baseline.
4 secondary outcomes
Number of Tumor Responders
Time frame: From Day 1 Until Disease Progression or Date of Death (Whichever Occurred First), Up to 1 Year
Median Time to Response
Time frame: From Day 1 Until Tumor Response
Median Duration of Response
Time frame: Day of 1st Response Until Disease Progression of Death/Last Contact
Median Overall Survival
Time frame: From Day 1 Until Death Occurred
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arkadiusz Dudek, MD principal investigator
Masonic Cancer Center, University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bevacizumab and topotecan hydrochloride in people with Lung Cancer, run by Masonic Cancer Center, University of Minnesota at 2 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 22 inclusion and 17 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 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 15 Jun 2012). 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?
Median Time to Disease Progression (time frame: From Day 1 Until First Documented Disease Progression or Date of Death (Whichever Occurred First)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2017.