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

Sponsors and Collaborators:	Cancer and Leukemia Group B National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
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 Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Etoposide Cisplatin Irinotecan Irinotecan hydrochloride Etoposide phosphate

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

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 ]

Study Start Date:

November 2003

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

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

Publications of Results:

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.

Study ID Numbers:	CDR0000339871, CALGB-30206
Study First Received:	November 4, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00072527
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

limited stage small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Irinotecan
Carboplatin
Etoposide phosphate
Camptothecin
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors

Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Enzyme Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009