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Combination Chemotherapy With or Without Maintenance Sunitinib Malate (IND 74019; NSC 736511) For Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/Randomized Phase II Study

Phase 1/Phase 2
18 Years
Open (Enrolling)
Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer

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Trial Information

Combination Chemotherapy With or Without Maintenance Sunitinib Malate (IND 74019; NSC 736511) For Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/Randomized Phase II Study


I. To determine the phase II dose for sunitinib combined with cisplatin and etoposide.

II. Phase II: To compare the progression-free survival of patients with extensive stage
small cell lung cancer treated with cisplatin or carboplatin and etoposide followed by
maintenance sunitinib to patients receiving the same chemotherapy followed by placebo.


I. To assess the single agent response rate for sunitinib given as monotherapy after

II. To assess the overall survival of patients treated with cisplatin or carboplatin and
etoposide followed by sunitinib.

III. To evaluate the toxicity and tolerability of maintenance sunitinib after cisplatin or
carboplatin and etoposide.

IV. To determine the association between VEGF plasma levels and tumor response.

OUTLINE: This is a phase I, dose-escalation study of sunitinib malate followed by a phase II
study. Patients are stratified according to treatment (cisplatin vs carboplatin), and
courses (< 6 courses vs 6 courses).

PHASE I: (close to accrual 5/17/08) Combination chemotherapy: Patients receive cisplatin or
carboplatin intravenously (IV) on day 1, etoposide IV on days 1-3, and sunitinib malate
orally (PO) once daily on days 1-14.

Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. Cohorts of 6 patients receive escalating doses of sunitinib malate
until the recommended phase II dose is determined. The recommended phase II dose is the dose
preceding that at which 2 of 6 patients experience dose-limiting toxicity.

MAINTENANCE THERAPY: Patients receive sunitinib malate PO alone once daily. Treatment
continues in the absence of disease progression or unacceptable toxicity.

PHASE II: Combination chemotherapy: Patients receive cisplatin or carboplatin and etoposide
as in phase I.

Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.

MAINTENANCE THERAPY: Beginning 3-8 weeks after completion of combination chemotherapy or ≥ 4
courses of combination therapy, patients with a responding or stable disease are randomized
to 1 of 2 treatment arms. All patients must be euthyroid before starting on maintenance

ARM I: Patients receive sunitinib malate PO once daily.

Treatment repeats every 3 weeks in the absence of disease progression or unacceptable

ARM II: Patients receive placebo PO once daily.

Treatment repeats every 3 weeks in the absence of disease progression or unacceptable
toxicity. Patients with disease progression may cross over to Arm I.

After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 2 years.

Inclusion Criteria:

- Histologically or cytologically confirmed small cell lung cancer

- Extensive-stage disease, defined as any of the following:

- Extrathoracic metastases

- Malignant pleural effusion

- Bilateral or contralateral supraclavicular adenopathy or contralateral
hilar adenopathy

- No limited-stage disease, defined as disease restricted to 1 hemithorax with
regional lymph node metastases, including hilar, ipsilateral and contralateral
mediastinal, and/or ipsilateral supraclavicular nodes

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan

- No nonmeasurable disease, including all of the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural or pericardial effusion

- Lymphangitis cutis/pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- No history of spinal cord compression or carcinomatous meningitis

- No history of brain metastases

- CTC performance status 0-1 (phase I) OR 0-2 (phase II)

- Absolute granulocyte count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Creatinine clearance ≥ 70 mL/min

- Bilirubin ≤ 1.5 mg/dL

- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN for patients with
liver metastases)

- PTT ≤ 1.5 ULN

- Not pregnant or nursing

- No current active second malignancy other than non-melanoma skin cancers

- No ongoing cardiac dysrhythmias or atrial fibrillation

- QTc interval < 500 msec

- No New York Heart Association (NYHA) class III-IV heart failure within the past 12

- NYHA class II heart failure allowed, provided all of the following criteria are

- Asymptomatic on treatment

- Prior anthracycline exposure

- Received prior central thoracic radiotherapy that included the heart in the
radiotherapy port

- None of the following within the past year:

- Myocardial infarction

- Coronary or peripheral artery bypass graft or stenting

- Severe or unstable angina

- Cerebrovascular accident, including transient ischemic attack

- Pulmonary embolism

- No hypertension that cannot be controlled by medications (i.e., blood pressure >
150/100 mm Hg despite optimal medical therapy)

- No hemoptysis within the past 4 weeks

- Patients with blood-tinged or blood-streaked sputum are eligible if < 5 mL of
blood per episode and < 10 mL of blood/24 hours

- None of the following within the past 28 days:

- Abdominal fistula

- Gastrointestinal perforation

- Intra-abdominal abscess

- Serious or nonhealing wound

- Ulcer

- Bone fracture

- No prior chemotherapy for small cell lung cancer

- At least 1 week since prior radiotherapy

- At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the

- Azole antifungals (e.g., ketoconazole, itraconazole)

- Diltiazem

- Clarithromycin

- Erythromycin

- Verapamil

- Delavirdine

- HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir,

- At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the

- Rifampin

- Rifabutin

- Carbamazepine

- Phenobarbital

- Phenytoin

- Hypericum perforatum (St. John's wort)

- Efavirenz

- Tipranavir

- No concurrent therapeutic doses of coumarin-derivative anticoagulants

- Doses ≤ 2 mg daily for prophylaxis of thrombosis allowed

- Concurrent low molecular weight heparin allowed provided PT INR ≤ 1.5

- No other concurrent chemotherapy

- No concurrent hormonal therapy

- Concurrent steroids for adrenal failure, hormones for non-disease-related
conditions (e.g., insulin for diabetes), or intermittent dexamethasone allowed

Type of Study:


Study Design:

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

Outcome Measure:

Highest safe dose of sunitinib malate in combination with cisplatin and etoposide (Phase I)

Outcome Time Frame:

Up to 21 days of course 1

Safety Issue:


Principal Investigator

Neal Ready

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

Related Keywords:

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



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