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

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00072527

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: cisplatin Drug: etoposide Drug: irinotecan hydrochloride Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	Induction Cisplatin/Irinotecan Followed By Combination Carboplatin, Etoposide And Chest Radiotherapy In Limited Stage Small Cell Lung Cancer: A Phase II Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Etoposide Carboplatin Irinotecan U 101440E Etoposide phosphate Irinotecan hydrochloride

U.S. FDA Resources

Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:

Efficacy, in terms of survival, at 2 years after initiation of study treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall response rate as measured by RECIST at completion of study treatment [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Failure-free survival [ Designated as safety issue: No ]
Response rate as measured by RECIST after completion of 2 courses of induction chemotherapy [ Designated as safety issue: No ]
Toxicity as measured by NCI CTCAE v.30 after completion of 2 courses of chemotherapy [ Designated as safety issue: Yes ]
Tolerability as measured by chemotherapy dose-delivered dose delays after completion of study treatment [ Designated as safety issue: Yes ]

Enrollment:	78
Study Start Date:	November 2003
Estimated Study Completion Date:	August 2019
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed small cell lung cancer (SCLC)
- Limited stage disease, defined as the following:
  - Disease restricted to 1 hemithorax with regional lymph node metastases, including hilar, ipsilateral, or contralateral mediastinal lymph nodes
  - No clinically suspected or confirmed supraclavicular lymph node metastases
  - No pathologically enlarged contralateral hilar lymph nodes
  - No pleural effusions that are visible on plain chest radiographs, whether they are cytologically positive or negative
Unidimensionally measurable disease
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- Pleural/pericardial effusions are not considered measurable

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin less than 1.5 mg/dL
AST less than 2 times upper limit of normal

Renal

Creatinine no greater than 2.0 mg/dL

Other

Not pregnant or nursing
Fertile patients must use effective contraception
No "currently active" second malignancy except nonmelanoma skin cancer
- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

No prior chemotherapy for SCLC
No other concurrent chemotherapy

Endocrine therapy

No concurrent hormonal therapy except the following:
- Steroids for adrenal failure
- Hormones administered for non-disease-related conditions (e.g., insulin for diabetes)
- Intermittent dexamethasone as an antiemetic or adjunct to prophylactic cranial radiotherapy

Radiotherapy

See Endocrine therapy
No prior radiotherapy for SCLC
No concurrent intensity-modulated radiotherapy

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072527

Show 76 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Michael J. Kelley, MD

Duke University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Kelley MJ, Bogart JA, Hodgson LD, et al.: CALGB 30206: phase II study of induction cisplatin (P) and irinotecan (I) followed by combination carboplatin (C), etoposide (E), and thoracic radiotherapy for limited stage small cell lung cancer. [Abstract] J Clin Oncol 25 (Suppl 18): A-7565, 400s, 2007.

Responsible Party:	Monica M Bertagnolli, MD, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00072527 History of Changes
Other Study ID Numbers:	CDR0000339871, U10CA031946, CALGB-30206
Study First Received:	November 4, 2003
Last Updated:	March 22, 2011
Health Authority:	United States: Federal Government

Keywords provided by Cancer and Leukemia Group B:

limited stage small cell lung cancer

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
Etoposide phosphate
Irinotecan
Cisplatin

Etoposide
Carboplatin
Camptothecin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012