Trial record 1 of 1 for:    CALGB-30504
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Cisplatin or Carboplatin, and Etoposide With or Without Sunitinib Malate in Treating Patients With Extensive-Stage Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00453154
First received: March 27, 2007
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

This phase I/II trial is studying the side effects and best dose of sunitinib malate and to see how well it works compared to a placebo when given together with cisplatin or carboplatin and etoposide in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin or carboplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cisplatin or carboplatin and etoposide are more effective when given with or without sunitinib malate in treating cancer.


Condition Intervention Phase
Extensive Stage Small Cell Lung Cancer
Recurrent Small Cell Lung Cancer
Drug: sunitinib malate
Drug: cisplatin
Drug: carboplatin
Drug: etoposide
Other: placebo
Other: laboratory biomarker analysis
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Highest safe dose of sunitinib malate in combination with cisplatin and etoposide (Phase I) [ Time Frame: Up to 21 days of course 1 ] [ Designated as safety issue: No ]
  • Progression-free survival (phase II) [ Time Frame: Time from randomization to disease progression and death of any cause, whichever comes first, assessed up to 3 years ] [ Designated as safety issue: No ]
    PFS will be conducted using a stratified one-sided log rank test with a significance level of 0.15. The Kaplan -Meier product limit estimator (17) will be used to graphically describe PFS for patients randomized to each treatment arm. From these product limit estimates, median survival and 6-week survival rate and their 95% confidence intervals by treatment arms will be computed.


Secondary Outcome Measures:
  • Dose-limiting toxicity (DLT) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) [ Time Frame: Up to 21 days, during course 1 ] [ Designated as safety issue: Yes ]
    Treatment-related toxicity will be summarized by grade, type and dose cohort.

  • Overall survival (OS) (Phase I) [ Time Frame: Time from registration to disease progression and death of any cause whichever comes first, assessed up to 3 years ] [ Designated as safety issue: No ]
    Dose-survival curve will be characterized by Kaplan-Meier product limit method and parametrically modeled using Cox's proportional hazard model.

  • Response rates (RR) (complete and partial response) (Phase I) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    RR will be estimated as well as 95% confidence intervals for SU11248 as a single agent and as part of the combination treatment.

  • OS rate (Phase II) [ Time Frame: Time from registration to death of any cause, assessed up to 10 months ] [ Designated as safety issue: No ]
    The Kaplan -Meier product limit estimator (17) will be used to graphically describe overall survival and progression free survival for patients randomized to each treatment arm. From these product limit estimates, median survival and 6-week survival rate and their 95% confidence intervals by treatment arms will be computed.

  • RR of single agent sunitinib (Phase II) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    The proportion of patients who respond (completely or partially) to each treatment regimen will be estimated as well as their 95% confidence intervals. Response rates (including complete and partial response) will be tested using Fisher's exact test and multivariately using a logistic regression model.

  • Toxicity and tolerability of maintenance sunitinib malate (Phase II) as assessed by the NCI CTCAE version 4.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 141
Study Start Date: March 2007
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (enzyme inhibitor therapy)
Patients receive sunitinib malate PO once daily.
Drug: sunitinib malate
Given PO
Other Names:
  • SU11248
  • sunitinib
  • Sutent
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Other: laboratory biomarker analysis
Correlative studies
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO once daily.
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Other: placebo
Given PO
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 months

    • NYHA class II heart failure allowed, provided all of the following criteria are met:

      • 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 following:

    • Azole antifungals (e.g., ketoconazole, itraconazole)
    • Diltiazem
    • Clarithromycin
    • Erythromycin
    • Verapamil
    • Delavirdine
    • HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, nelfinavir)
  • At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:

    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453154

  Show 117 Study Locations
Sponsors and Collaborators
Investigators
Principal Investigator: Neal Ready Cancer and Leukemia Group B
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00453154     History of Changes
Other Study ID Numbers: NCI-2009-00465, NCI-2009-00465, CDR0000538229, CALGB-30504, CALGB 30504, CALGB-30504, U10CA031946, P30CA014236
Study First Received: March 27, 2007
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Sunitinib
Carboplatin
Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014