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Lung CancerPhase 2NCT00072527

Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

A Phase 2 study testing carboplatin, cisplatin and etoposide in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 76 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, irinotecan, carboplatin, and etoposide, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
carboplatin, cisplatin and etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
76 sitesUnited States
Study dates
Nov 2003to Jan 2013
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
  1. Histologically or cytologically documented small cell lung cancer of limited stage. 1.1 Limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal lymph nodes. 1.2 Although they are usually defined as having limited stage small cell lung cancer, because of concern about the volume of the radiation field that would be required, patients with clinically suspected or confirmed supraclavicular lymph node metastases, patients with pathologically enlarged contralateral hilar lymph nodes, and patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not, are NOT eligible.
  2. All Patients must have Measurable Disease 2.1 Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan. 2.2 Pleural/pericardial effusions are not considered measurable.
  3. Age ≥18
  4. ECOG Performance status 0-2.
  5. Prior Treatment - No prior chemotherapy or radiotherapy for SCLC.
  6. No "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
  7. Non-pregnant and non-nursing because of significant risk to the fetus/infant.
  8. Required Initial Laboratory Values
  • Granulocytes ≥1,500/µl
  • Platelets ≥100,000/µl
  • Serum Creatinine ≤ULN
  • Bilirubin <1.5 mg/dl
  • SGOT (AST) <2 x ULN

Trial locations and contacts

76 sites in 1 country.

76 sites in 1 country

United States76 sites

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215

  • Cancer Institute of New Jersey at the Cooper University Hospital

    Camden, New Jersey, 08103

  • Graham Hospital

    Canton, Illinois, 61520

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital Cancer Center at Union Hospital

    Elkton MD, Maryland, 21921

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Hudner Oncology Center at Saint Anne's Hospital

    Fall River, Massachusetts, 02721

  • Fort Wayne Medical Oncology and Hematology, Incorporated

    Fort Wayne, Indiana, 46815

  • Galesburg Clinic

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • InterCommunity Cancer Center of Western Illinois

    Galesburg, Illinois, 61401

  • Comprehensive Cancer Center at Gaston Memorial

    Gastonia, North Carolina, 28053

  • Charles R. Wood Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Bon Secours St. Francis Health System

    Greenville, South Carolina, 29601

  • Greenville Hospital System Cancer Center

    Greenville, South Carolina, 29605

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Mason District Hospital

    Havana, Illinois, 62644

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Kingsbury Center for Cancer Care at Cheshire Medical Center

    Keene, New Hampshire, 03431

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Lenoir Memorial Cancer Center

    Kinston, North Carolina, 28501

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Fairview University Medical Center - University Campus

    Minneapolis, Minnesota, 55455

  • Mercy Memorial Hospital System

    Monroe, Michigan, 48162

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11042

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19718

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Methodist Cancer Center at Methodist Hospital - Omaha

    Omaha, Nebraska, 68114

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois - Ottawa

    Ottawa, Illinois, 61350

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology/Hematology Associates of Central Illinois, P.C.

    Peoria, Illinois, 61615

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Comprehensive Cancer Center at Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Saint Joseph Regional Medical Center - Plymouth Campus

    Plymouth, Indiana, 46544

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Miriam Hospital at Lifespan

    Providence, Rhode Island, 02906

  • Frisbie Memorial Hospital

    Rochester, New Hampshire, 03867

  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • St. Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Valley Cancer Center

    Spring Valley, Illinois, 61362

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York, 13057

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Community General Hospital of Greater Syracuse

    Syracuse, New York, 13215

  • Faxton Regional Cancer Center

    Utica, New York, 13502

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307

  • St. Francis Hospital

    Wilmington, Delaware, 19805

  • Zimmer Cancer Center at New Hanover Regional Medical Center

    Wilmington, North Carolina, 28401

  • Forsyth Regional Cancer Center at Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Induction Cisplatin/Irinotecan Followed By Combination Carboplatin, Etoposide And Chest Radiotherapy In Limited Stage Small Cell Lung Cancer: A Phase II Study

RATIONALE: Drugs used in chemotherapy, such as cisplatin, irinotecan, carboplatin, and etoposide, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin and irinotecan followed by carboplatin, etoposide, and radiation therapy in treating patients who have limited-stage small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the efficacy of cisplatin and irinotecan followed by carboplatin, etoposide, and radiotherapy, in terms of 2-year survival, in patients with limited stage small cell lung cancer.

Secondary

  • Determine the overall response rate, overall survival, and failure-free survival of patients treated with this regimen.
  • Determine the response rate in patients treated with induction therapy comprising irinotecan and cisplatin.
  • Determine the toxicity and tolerability of this regimen in these patients.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
  • Consolidation therapy: Immediately after the completion of induction therapy, patients receive carboplatin IV over 60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
  • Radiotherapy: Beginning on day 1 of consolidation therapy, patients undergo chest radiotherapy daily 5 days a week for 6-7 weeks.

After the completion of consolidation therapy, patients who achieve a complete remission or very good partial remission may undergo prophylactic radiotherapy to the brain.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 15-24 months.

Conditions
Lung Cancer
Being tested
carboplatin, cisplatin, etoposide, irinotecan hydrochloride, radiation therapy
Keywords
limited stage small cell lung cancer
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00072527
Study groupRoleWhat they receive
Induction and consolidation chemotherapyExperimentalInduction chemotherapy (Cycles 1 and 2): Patients receive cisplatin 30 mg/m^2 on days 1, 8, 22 and 29 and irinotecan 65 mg/m^2 on days 1, 8, 22 and 29 for cycles 1 and 2. Consolidation chemotherapy (Cycles 3, 4 and 5 beginning on day 43, week 7): Patients receive carboplatin on days 43, 64 and 85, etoposide 100 mg/m^2 IV on days 43-45, 64-66 and 85-87 and XRT 5 fractions/week starting on day 43
Receives: Drug: carboplatin; Drug: cisplatin; Drug: etoposide; Drug: irinotecan hydrochloride; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy, in terms of survival, at 2 years after initiation of study treatment

Secondary outcomes (6)

  1. Overall response rate as measured by RECIST at completion of study treatment

  2. Overall survival

  3. Failure-free survival

  4. Response rate as measured by RECIST after completion of 2 courses of induction chemotherapy

  5. Toxicity as measured by NCI CTCAE v.30 after completion of 2 courses of chemotherapy

  6. Tolerability as measured by chemotherapy dose-delivered dose delays after completion of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2003 (estimated)
  2. Study startNov 2003
  3. Primary completionJun 2007
  4. Study completionJan 2013

Resources

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
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00072527
Sponsor's protocol ID
CALGB-30206
Other IDs
U10CA031946, CDR0000339871
Status last verified
Jul 2016
First submitted
4 Nov 2003
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Kelley MJ, Bogart JA, Hodgson LD, Ansari RH, Atkins JN, Pang H, Green MR, Vokes EE. Phase II study of induction cisplatin and irinotecan followed by concurrent carboplatin, etoposide, and thoracic radiotherapy for limited-stage small-cell lung cancer, CALGB 30206. J Thorac Oncol. 2013 Jan;8(1):102-8. doi: 10.1097/JTO.0b013e31827628e1.

    PubMed 23196276

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, cisplatin and etoposide in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 76 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?

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 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 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?

Efficacy, in terms of survival, at 2 years after initiation of study treatment. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00072527, which also lists 1 linked publication.

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 6 Jul 2016.

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