Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00294931
NCT00294931CompletedPhase 2

A Phase II Trial of Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer

SCRI Development Innovations, LLC4 sites in 1 country50 target enrollmentStarted: February 1, 2006Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
50
Locations
4
Primary Endpoint
median time to progression
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

median time to progression

Secondary Outcomes

  • duration of response
  • overall survival
  • overall toxicity
  • overall response rate

Investigators

Sponsor Class
Other

Study Sites (4)

Loading locations...

Similar Trials

Completed
Phase 2
Irinotecan and Carboplatin as First-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung CancerLung Cancer
NCT00469898Vanderbilt-Ingram Cancer Center50
Completed
Phase 2
Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Limited Stage Small Cell Lung CancerCarcinoma, Small Cell LungLung Cancer
NCT00308529SCRI Development Innovations, LLC55
Completed
Phase 2
A Phase II Study of Carboplatin Plus Irinotecan Versus Irinotecan in Children With Refractory Solid TumorsNeoplasms
NCT00057473Bristol-Myers Squibb
Completed
Phase 2
Irinotecan, Cisplatin, and Bevacizumab in Treating Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction AdenocarcinomaAdenocarcinoma of the Gastroesophageal JunctionDiffuse Adenocarcinoma of the StomachIntestinal Adenocarcinoma of the StomachMixed Adenocarcinoma of the StomachRecurrent Gastric CancerStage IIIA Gastric CancerStage IIIB Gastric CancerStage IIIC Gastric CancerStage IV Gastric Cancer
NCT00084604National Cancer Institute (NCI)47
Completed
Phase 2
Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid LeukemiaAdult Acute Myeloblastic Leukemia Without Maturation (M1)Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myelomonocytic Leukemia (M4)Adult Acute Myeloblastic Leukemia With Maturation (M2)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Adult Acute Monoblastic Leukemia (M5a)Adult Acute Monocytic Leukemia (M5b)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Recurrent Adult Acute Myeloid LeukemiaAdult Acute Megakaryoblastic Leukemia (M7)Adult Acute Minimally Differentiated Myeloid Leukemia (M0)Adult Erythroleukemia (M6a)Adult Pure Erythroid Leukemia (M6b)
NCT00634244National Cancer Institute (NCI)92