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Cisplatin, Irinotecan and Bevacizumab (NSC #704865, IND #7921) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase II Study

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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

Gender: Both
Steward Physician(s)
  • Neal Ready, MD, PhD
Facilities
  • Saint Anne's Hospital - Completed
Trial Interventions
Biological
  • bevacizumab
Drug
  • cisplatin
  • irinotecan hydrochloride
Physician Researcher

Investigator Name:

  • Neal Ready, MD, PhD

Other Information

Sponsor: Cancer and Leukemia Group B
Phase: Phase 2
Trial ID: NCT00118235
Volunteers:  Not Accepting Healthy Volunteers

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