Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
Genentech
Pharmacia and Upjohn
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193375
First received: September 12, 2005
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

In this multicenter trial, we plan to evaluate the feasibility and toxicity of initial treatment with irinotecan/carboplatin/radiation therapy, followed by treatment with bevacizumab, in patients with limited stage small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: Irinotecan
Drug: Carboplatin
Drug: Bevacizumab
Radiation: Radiation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Concurrent Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab (Avastin) in the Treatment of Patients With Limited Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3.


Secondary Outcome Measures:
  • 2-Year Progression-free Survival (PFS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) was defined as the date of study entry until the date of tumor progression or death. 2-Year PFS is the percentage of patients alive and without progressive disease (PD) 2 years from the date of study entry.

  • Overall Response Rate [ Time Frame: 18 month ] [ Designated as safety issue: No ]
    Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.


Enrollment: 60
Study Start Date: August 2003
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
Drug: Irinotecan
50mg/m2 days 1 & 8 each 21-day cycle 1 & 2, 28-day cycle 3 & 4
Other Name: Camptosar
Drug: Carboplatin
AUC 5
Other Name: Paraplatin
Drug: Bevacizumab
10mg/kg IV every 2 weeks for 10 doses starting week 16
Other Name: Avastin
Radiation: Radiation

Detailed Description:

Upon determination of eligibility, all patients will be receive:

  • Irinotecan + Carboplatin + Radiation Therapy + Bevacizumab

Patients will receive 4 courses of irinotecan/carboplatin. Radiation therapy will begin concurrently with the third course of chemotherapy. The intervals between chemotherapy courses will be 21 days except for the interval between the third and fourth courses (during radiation therapy), which will be 28 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

  • Small cell lung cancer, confirmed by biopsy.
  • Limited stage disease after standard evaluation.
  • Able to perform activities of daily living without assistance.
  • No previous treatment with chemotherapy, radiation therapy, or biologics.
  • Measurable or evaluable disease
  • Adequate bone marrow, liver and kidney function
  • Able to understand the nature of this study and give written consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Age < 18 years
  • History of previous malignancies
  • Women pregnant or lactating
  • History or physical exam evidence of central nervous system disease)
  • Active infection requiring intravenous antibiotics
  • Full-dose anticoagulation or thrombolytic therapy within 10 days
  • Proteinuria.
  • Serious nonhealing wound, ulcer, or bone fracture
  • Evidence if bleeding diathesis or coagulopathy
  • History of heart attack within 6 months.
  • Uncontrolled cardiovascular disease
  • PEG or G-tube
  • History of other serious disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193375

Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech
Pharmacia and Upjohn
Investigators
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
  More Information

Publications:
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193375     History of Changes
Other Study ID Numbers: SCRI LUN 72
Study First Received: September 12, 2005
Results First Received: October 5, 2012
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Irinotecan
Bevacizumab
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014