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Cisplatin, Irinotecan, and Bevacizumab in Treating Patients With Extensive-Stage Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: July 8, 2005   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00118235
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Lung Cancer
Biological: bevacizumab
Drug: cisplatin
Drug: irinotecan hydrochloride
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Cisplatin Irinotecan U 101440E Irinotecan hydrochloride Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Cisplatin, Irinotecan and Bevacizumab (NSC #704865, IND #7921) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase II Study

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

Primary Outcome Measures:
  • Survival time [ Designated as safety issue: No ]

Study Start Date: December 2004
Detailed Description:

OBJECTIVES:

Primary

  • Determine the 12-month overall survival rate in patients with extensive-stage small cell lung cancer treated with cisplatin, irinotecan, and bevacizumab.

Secondary

  • Determine the response rate in patients treated with this regimen.
  • Determine the toxicity and tolerability of this regimen in these patients.
  • Correlate vascular endothelial growth factor (VEGF)/VEGF receptor_2 expression and VEGF plasma levels with tumor response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

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.

PROJECTED ACCRUAL: A total of 10-72 patients will be accrued for this study within 7-12 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)

    • Extensive-stage disease, defined by 1 of the following:

      • Extrathoracic metastases
      • Malignant pleural effusion
      • Bilateral or contralateral supraclavicular adenopathy
      • Contralateral hilar adenopathy
  • Measurable or nonmeasurable disease

    • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
    • The following are considered nonmeasurable disease:

      • Bones lesions
      • Ascites
      • Pleural or pericardial effusion
      • Lymphangitis cutis or pulmonis
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
  • No limited stage disease, defined as disease confined to 1 hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes
  • No CNS metastases by brain CT scan or MRI, including CNS metastases previously treated with 1 course of CNS radiotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No history of bleeding diathesis
  • No history of other significant bleeding episodes

Hepatic

  • INR < 1.5
  • PTT < 1.2 times upper limit normal (ULN)
  • Bilirubin < 2.0 mg/dL
  • SGOT < 2 times ULN

Renal

  • Creatinine normal
  • Urine protein < 1+ OR
  • Urine protein < 1 g by 24-hour urine collection

Cardiovascular

  • No New York Heart Association class II-IV congestive heart failure
  • No myocardial infarction within the past year
  • No significant change in anginal pattern within the past year
  • No cerebrovascular accident within the past 6 months
  • No clinically significant peripheral arterial disease
  • No uncontrolled hypertension (i.e., blood pressure ≥ 150/90 mm Hg despite antihypertensive therapy)

Pulmonary

  • No hemoptysis

    • Trace blood in the sputum allowed

Other

  • Not pregnant
  • No nursing during and for ≥ 3-4 months after completion of study treatment
  • Fertile patients must use effective contraception during and for ≥ 3-4 months after completion of study treatment
  • No serious or non-healing wound ulcer or bone fracture
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No other active malignancy except nonmelanoma skin cancer
  • No peripheral neuropathy ≥ grade 2
  • No upper or lower gastrointestinal bleeding

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for SCLC
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy

Surgery

  • More than 4 weeks since prior major surgery and recovered
  • More than 1 week since prior minor surgery (e.g., mediastinoscopy or core biopsy)

Other

  • More than 1 month since prior and no concurrent thrombolytic agents except low-dose thrombolytic therapy for maintenance of central venous catheters
  • No prior investigational therapy for SCLC
  • No concurrent chronic daily aspirin treatment (> 325 mg/day) or non-steroidal anti-inflammatory agents known to inhibit platelet function
  • No concurrent dipyridamole, ticlopidine, clopidogrel, cilostazol, or other antiplatelet agents
  • No concurrent therapeutic anticoagulation

    • Concurrent prophylactic anticoagulation for central venous access devices allowed provided requirements for INR and PTT are met
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118235

  Show 87 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Neal Ready, MD, PhD Rhode Island Hospital Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Ready N, Dudek AZ, Wang XF, et al.: CALGB 30306: a phase II study of cisplatin (C), irinotecan (I) and bevacizumab (B) for untreated extensive stage small cell lung cancer (ES-SCLC). [Abstract] J Clin Oncol 25 (Suppl 18): A-7563, 400s, 2007.

Study ID Numbers: CDR0000433341, CALGB-30306
Study First Received: July 8, 2005
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00118235     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
extensive stage small cell lung cancer
recurrent small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Irinotecan
Bevacizumab
Angiogenesis Inhibitors
Camptothecin
Recurrence
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Radiation-Sensitizing Agents
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Carcinoma, Neuroendocrine
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Irinotecan
Bevacizumab
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Growth Substances
Enzyme Inhibitors
Angiogenesis Inhibitors
Camptothecin
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases

ClinicalTrials.gov processed this record on May 07, 2009