Clinical trial NCT00294931: Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer
Official title: A Phase II Trial of Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Small Cell Lung
Keywords: Lung Cancer, Small Cell
Extensive
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2006-02-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multicenter phase II trial is designed to study the unique combination of chemotherapy (irinotecan./carboplatin) and bevacizumab in the extensive-stage setting. This clinical setting seems ideal for evaluation of the role of bevacizumab in delaying progression and prolonging survival.

Detailed description: Eligible patients will receive 6 courses of irinotecan, carboplatin, and bevacizumab. The interval between chemotherapy courses will be 28 days. If after 6 courses of treatment, patient's response is a CR/PR/SD they will continue on Bevacizumab until tumor progression or up to 6 cycles (6 months) total.

Treatment sequence:

* Irinotecan 60mg/m2 on days 1, 8, and 15
* Carboplatin AUC=4 day 1 only
* Bevacizumab 10 mg/kg days 1 and 15

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed small cell lung cancer,extensive stage disease.
* Measurable or evaluable disease
* No previous chemotherapy
* Able to perform activities of daily living with minimal assistance
* Adequate hematological, live and kidney function
* Provide written informed consent

Exclusion Criteria:

* Limited stage disease
* PEG or G tubes
* Hemoptysis
* Abdominal fistula, perforation, or abscess within the previous 6 months
* Women who are pregnant or lactating
* Proteinuria
* Serious nonhealing wound, ulcer, or bone fracture
* Evidence of bleeding diathesis or coagulopathy
* Uncontrolled or serious cardiovascular disease
* Uncontrolled brain metastasis
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days; Fine needle aspiration within 7 days
* Patients requiring full-dose anticoagulation must be on a stable dosing schedule prior to enrollment

Primary outcomes:
measure: median time to progression
Secondary outcomes:
measure: overall toxicity
measure: overall response rate
measure: duration of response
measure: overall survival
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Associates
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: David R. Spigel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spigel DR, Greco FA, Zubkus JD, Murphy PB, Saez RA, Farley C, Yardley DA, Burris HA 3rd, Hainsworth JD. Phase II trial of irinotecan, carboplatin, and bevacizumab in the treatment of patients with extensive-stage small-cell lung cancer. J Thorac Oncol. 2009 Dec;4(12):1555-60. doi: 10.1097/JTO.0b013e3181bbc540.