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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT00365547•Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
•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,
+12 more criteria

Exclusion Criteria

•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
•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
+7 more criteria

Locations (2)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, United States

Key Dates

Start Date

September 1, 2006

Primary Completion Date

September 1, 2011

Completion Date

September 1, 2011

Last Updated

December 28, 2017

Enrollment

ACTUAL participants

Conditions

Lung Cancer

Interventions

bevacizumab

BIOLOGICAL

topotecan hydrochloride

DRUG

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NCT05692635

Brain MetastasesNonsmall Cell Lung Cancer Stage III

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 28, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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