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

Phase 2
18 Years
Not Enrolling
Extensive Stage Small Cell Lung Cancer

Thank you

Trial Information

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


I. To determine the percentage of patients with extensive stage small cell lung cancer
treated with cisplatin, irinotecan and bevacizumab who live longer than 12 months.


I. To assess the response rate of patients treated with cisplatin, irinotecan and

II. To evaluate the toxicity and tolerability of the combination of cisplatin, irinotecan
and bevacizumab.

III. To determine the association between VEGF/KDR complex expression and VEGF plasma levels
and tumor response.


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

After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 3 years.

Inclusion Criteria:

- All patients must have histologically or cytologically documented small cell
carcinoma of the bronchus

- The extensive disease classification for this protocol includes all patients with
disease sites not defined as limited stage; limited stage disease category includes
patients with disease restricted to one hemithorax with regional lymph node
metastases, including hilar, ipsilateral and contralateral mediastinal, and/or
ipsilateral supraclavicular nodes; extensive stage patients are defined as those
patients with extrathoracic metastases, malignant pleural effusion, bilateral or
contralateral supraclavicular adenopathy or contralateral hilar adenopathy

- Measurable or Non-measurable Disease

- No prior chemotherapy or investigational therapy for SCLC

- Radiation therapy must have been completed at least three weeks before initiation of
protocol therapy

- No major surgical procedure within 28 days prior to starting treatment and fully

- No minor surgical procedure (mediastinoscopy or core biopsy) within 7 days prior to
starting treatment

- ECOG performance status: 0-2

- No "currently active" second malignancy other than non-melanoma skin cancers

- No CNS metastases; patients with a history of CNS metastases will NOT be eligible
even if they have completed a course of CNS radiotherapy; all patients will have a
screening brain CT or MRI to rule out occult CNS metastases

- No recent history of CVA (within 6 months)

- No serious or non-healing wound ulcer or bone fracture

- Patients with a history of significant bleeding episodes (e.g., hemoptysis, bleeding
diathesis, upper or lower GI bleeding) are not eligible; patients with trace blood in
the sputum ("blood tinged sputum") are eligible

- No myocardial infarction or significant change in anginal pattern within one year or
current congestive heart failure (NYHA Class 2 or higher)

- Patients with a history of hypertension must be well controlled (< 150/90) on a
stable regimen of anti-hypertensive therapy

- No HIV-positive patients receiving combination anti-retroviral therapy because of
possible pharmacokinetic interactions with the protocol treatment; (patients with
immune deficiency are at an increased risk of lethal infections when treated with
marrow-suppressive therapy)

- No chronic daily treatment with aspirin (> 325 mg/day) or on non-steroidal
antiinflammatory agents known to inhibit platelet function; no treatment with
dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), cilostazol
(Pletal), or other antiplatelet agents

- No clinically significant peripheral neuropathy (grade >= 2)

- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human antibodies

- No treatment with therapeutic anticoagulation; prophylactic anticoagulation for
central venous access devices is allowed provided requirements of INR < 1.5 and PTT <
1.2 x ULN are met; caution should be taken in treating patients with low dose heparin
or low molecular weight heparin for DVT prophylaxis as there may be an increased
bleeding risk with bevacizumab

- No current and/or recent (within 1 month) use of a thrombolytic agent; low dose
thrombolytic therapy for maintenance of central venous catheter is allowed

- No clinically significant peripheral arterial disease

- Non-pregnant and non-nursing; the effect of the combination of bevacizumab,
cisplatin, and irinotecan on the fetus and infant is unknown

- Granulocytes >= 1,500/μl

- Platelets >= 100,000/μl

- Serum Creatinine =< ULN

- Total Bilirubin < 2.0 mg/dl

- SGOT < 2 x ULN

- INR < 1.5

- PTT < 1.2 x ULN

- Urine protein (dipstick) < 1+

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival time

Outcome Description:

Described using Kaplan-Meier curves.

Outcome Time Frame:

The time beginning at randomization until death or last known follow-up, assessed up to 4 years

Safety Issue:


Principal Investigator

Neal Ready

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B (CALGB) Research Base


United States: Food and Drug Administration

Study ID:




Start Date:

December 2004

Completion Date:

Related Keywords:

  • Extensive Stage Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Rhode Island Hospital Providence, Rhode Island  02903