Extensive Stage Small Cell Lung CancerPhase 2NCT00118235
Cisplatin, Irinotecan, and Bevacizumab, in Treating Patients With Small Cell Lung Cancer
A Phase 2 study testing cisplatin, irinotecan hydrochloride and bevacizumab in people with Extensive Stage Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer
- What is being tested?
- cisplatin, irinotecan hydrochloride and bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2004to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 31Show fewer
- 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+
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cancer and Leukemia Group B
Chicago, Illinois, 60606
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Cisplatin, Irinotecan and Bevacizumab (NSC# 704865) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase II Study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Being tested
- cisplatin, irinotecan hydrochloride, bevacizumab, laboratory biomarker analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
Also called CACP, CDDP, CPDD, DDP
Given IV
Also called Campto, Camptosar, CPT-11, irinotecan
Given IV
bevacizumabBiological
Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Given IV
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (cisplatin, irinotecan hydrochloride, bevacizumab) | Experimental | 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. Receives: Drug: cisplatin; Drug: irinotecan hydrochloride; Biological: bevacizumab; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival time
Described using Kaplan-Meier curves.
Measured: The time beginning at randomization until death or last known follow-up, assessed up to 4 years
Failure-free survival
Described using Kaplan-Meier curves.
Measured: The time between randomization and the occurrence of disease progression, or death, whichever comes first, assessed up to 4 years
Secondary outcomes (1)
Frequency of toxicity, tabulated by the most severe occurrence
Graded using the NCI CTCAE version 3.0.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2005 (estimated)
- Study startDec 2004
- Primary completionApr 2007
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Neal Ready, Principal investigator, Cancer and Leukemia Group B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118235
- Sponsor's protocol ID
- NCI-2012-02815
- Other IDs
- NCI-2012-02815, CDR0000433341, CALGB-30306, CALGB-30306, U10CA031946, P30CA014236
- Status last verified
- Dec 2012
- First submitted
- 8 Jul 2005
- Last updated
- 17 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cisplatin, Irinotecan and Bevacizumab (NSC# 704865) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase II Study
- ClinicalTrials.gov ID
- NCT00118235
- Acronym / sponsor ID
- NCI-2012-02815
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 11 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (cisplatin, irinotecan hydrochloride, bevacizumab) | Experimental | Drug: cisplatin, Drug: irinotecan hydrochloride, Biological: bevacizumab, Other: laboratory biomarker analysisPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatinAlso: CACP, CDDP, CPDD, DDPGiven IV | Drug | Treatment (cisplatin, irinotecan hydrochloride, bevacizumab) |
| irinotecan hydrochlorideAlso: Campto, Camptosar, CPT-11, irinotecanGiven IV | Drug | Treatment (cisplatin, irinotecan hydrochloride, bevacizumab) |
| bevacizumabAlso: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGFGiven IV | Biological | Treatment (cisplatin, irinotecan hydrochloride, bevacizumab) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (cisplatin, irinotecan hydrochloride, bevacizumab) |
Primary outcome
Survival time
Time frame: The time beginning at randomization until death or last known follow-up, assessed up to 4 years
Described using Kaplan-Meier curves.
Failure-free survival
Time frame: The time between randomization and the occurrence of disease progression, or death, whichever comes first, assessed up to 4 years
Described using Kaplan-Meier curves.
1 secondary outcome
Frequency of toxicity, tabulated by the most severe occurrence
Time frame: Up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal Ready principal investigator
Cancer and Leukemia Group B
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin, irinotecan hydrochloride and bevacizumab in people with Extensive Stage Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival time (time frame: The time beginning at randomization until death or last known follow-up, assessed up to 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2014.