search
Back to results

Cisplatin, Irinotecan, and Bevacizumab, in Treating Patients With Small Cell Lung Cancer

Primary Purpose

Extensive Stage Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
irinotecan hydrochloride
bevacizumab
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients must have histologically or cytologically documented small cell carcinoma of the bronchus The extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive stage patients are defined as those patients with extrathoracic metastases, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy Measurable or Non-measurable Disease No prior chemotherapy or investigational therapy for SCLC Radiation therapy must have been completed at least three weeks before initiation of protocol therapy No major surgical procedure within 28 days prior to starting treatment and fully recovered No minor surgical procedure (mediastinoscopy or core biopsy) within 7 days prior to starting treatment ECOG performance status: 0-2 No "currently active" second malignancy other than non-melanoma skin cancers No CNS metastases; patients with a history of CNS metastases will NOT be eligible even if they have completed a course of CNS radiotherapy; all patients will have a screening brain CT or MRI to rule out occult CNS metastases No recent history of CVA (within 6 months) No serious or non-healing wound ulcer or bone fracture Patients with a history of significant bleeding episodes (e.g., hemoptysis, bleeding diathesis, upper or lower GI bleeding) are not eligible; patients with trace blood in the sputum ("blood tinged sputum") are eligible No myocardial infarction or significant change in anginal pattern within one year or current congestive heart failure (NYHA Class 2 or higher) Patients with a history of hypertension must be well controlled (< 150/90) on a stable regimen of anti-hypertensive therapy No HIV-positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with the protocol treatment; (patients with immune deficiency are at an increased risk of lethal infections when treated with marrow-suppressive therapy) No chronic daily treatment with aspirin (> 325 mg/day) or on non-steroidal antiinflammatory agents known to inhibit platelet function; no treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), cilostazol (Pletal), or other antiplatelet agents No clinically significant peripheral neuropathy (grade >= 2) No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies No treatment with therapeutic anticoagulation; prophylactic anticoagulation for central venous access devices is allowed provided requirements of INR < 1.5 and PTT < 1.2 x ULN are met; caution should be taken in treating patients with low dose heparin or low molecular weight heparin for DVT prophylaxis as there may be an increased bleeding risk with bevacizumab No current and/or recent (within 1 month) use of a thrombolytic agent; low dose thrombolytic therapy for maintenance of central venous catheter is allowed No clinically significant peripheral arterial disease Non-pregnant and non-nursing; the effect of the combination of bevacizumab, cisplatin, and irinotecan on the fetus and infant is unknown Granulocytes >= 1,500/μl Platelets >= 100,000/μl Serum Creatinine =< ULN Total Bilirubin < 2.0 mg/dl SGOT < 2 x ULN INR < 1.5 PTT < 1.2 x ULN Urine protein (dipstick) < 1+

Sites / Locations

  • Cancer and Leukemia Group B
  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (cisplatin, irinotecan hydrochloride, bevacizumab)

Arm Description

Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Survival time
Described using Kaplan-Meier curves.
Failure-free survival
Described using Kaplan-Meier curves.

Secondary Outcome Measures

Frequency of toxicity, tabulated by the most severe occurrence
Graded using the NCI CTCAE version 3.0.

Full Information

First Posted
July 8, 2005
Last Updated
June 16, 2014
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00118235
Brief Title
Cisplatin, Irinotecan, and Bevacizumab, in Treating Patients With Small Cell Lung Cancer
Official Title
Cisplatin, Irinotecan and Bevacizumab (NSC# 704865) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This phase II trial is studying how well giving cisplatin and irinotecan together with bevacizumab works in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and irinotecan, 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 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 small cell lung cancer by blocking blood flow to the tumor. Giving cisplatin and irinotecan together with bevacizumab may kill more tumor cells.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the percentage of patients with extensive stage small cell lung cancer treated with cisplatin, irinotecan and bevacizumab who live longer than 12 months. SECONDARY OBJECTIVES: I. To assess the response rate of patients treated with cisplatin, irinotecan and bevacizumab. II. To evaluate the toxicity and tolerability of the combination of cisplatin, irinotecan and bevacizumab. III. To determine the association between VEGF/KDR complex expression and VEGF plasma levels and tumor response. OUTLINE: Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive Stage Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (cisplatin, irinotecan hydrochloride, bevacizumab)
Arm Type
Experimental
Arm Description
Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
CACP, CDDP, CPDD, DDP
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Other Intervention Name(s)
Campto, Camptosar, CPT-11, irinotecan, U-101440E
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
bevacizumab
Other Intervention Name(s)
anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Survival time
Description
Described using Kaplan-Meier curves.
Time Frame
The time beginning at randomization until death or last known follow-up, assessed up to 4 years
Title
Failure-free survival
Description
Described using Kaplan-Meier curves.
Time Frame
The time between randomization and the occurrence of disease progression, or death, whichever comes first, assessed up to 4 years
Secondary Outcome Measure Information:
Title
Frequency of toxicity, tabulated by the most severe occurrence
Description
Graded using the NCI CTCAE version 3.0.
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients must have histologically or cytologically documented small cell carcinoma of the bronchus The extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive stage patients are defined as those patients with extrathoracic metastases, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy Measurable or Non-measurable Disease No prior chemotherapy or investigational therapy for SCLC Radiation therapy must have been completed at least three weeks before initiation of protocol therapy No major surgical procedure within 28 days prior to starting treatment and fully recovered No minor surgical procedure (mediastinoscopy or core biopsy) within 7 days prior to starting treatment ECOG performance status: 0-2 No "currently active" second malignancy other than non-melanoma skin cancers No CNS metastases; patients with a history of CNS metastases will NOT be eligible even if they have completed a course of CNS radiotherapy; all patients will have a screening brain CT or MRI to rule out occult CNS metastases No recent history of CVA (within 6 months) No serious or non-healing wound ulcer or bone fracture Patients with a history of significant bleeding episodes (e.g., hemoptysis, bleeding diathesis, upper or lower GI bleeding) are not eligible; patients with trace blood in the sputum ("blood tinged sputum") are eligible No myocardial infarction or significant change in anginal pattern within one year or current congestive heart failure (NYHA Class 2 or higher) Patients with a history of hypertension must be well controlled (< 150/90) on a stable regimen of anti-hypertensive therapy No HIV-positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with the protocol treatment; (patients with immune deficiency are at an increased risk of lethal infections when treated with marrow-suppressive therapy) No chronic daily treatment with aspirin (> 325 mg/day) or on non-steroidal antiinflammatory agents known to inhibit platelet function; no treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), cilostazol (Pletal), or other antiplatelet agents No clinically significant peripheral neuropathy (grade >= 2) No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies No treatment with therapeutic anticoagulation; prophylactic anticoagulation for central venous access devices is allowed provided requirements of INR < 1.5 and PTT < 1.2 x ULN are met; caution should be taken in treating patients with low dose heparin or low molecular weight heparin for DVT prophylaxis as there may be an increased bleeding risk with bevacizumab No current and/or recent (within 1 month) use of a thrombolytic agent; low dose thrombolytic therapy for maintenance of central venous catheter is allowed No clinically significant peripheral arterial disease Non-pregnant and non-nursing; the effect of the combination of bevacizumab, cisplatin, and irinotecan on the fetus and infant is unknown Granulocytes >= 1,500/μl Platelets >= 100,000/μl Serum Creatinine =< ULN Total Bilirubin < 2.0 mg/dl SGOT < 2 x ULN INR < 1.5 PTT < 1.2 x ULN Urine protein (dipstick) < 1+
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Ready
Organizational Affiliation
Cancer and Leukemia Group B
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer and Leukemia Group B
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60606
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cisplatin, Irinotecan, and Bevacizumab, in Treating Patients With Small Cell Lung Cancer

We'll reach out to this number within 24 hrs