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A Randomized Double Blind Phase II Trial of Cisplatin Plus Etoposide With/Without Concurrent ZD6474 in Patients With Previously Untreated Extensive Stage Small Cell Lung Cancer: Hoosier Oncology Group LUN06-113


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Small Cell Lung Cancer

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Trial Information

A Randomized Double Blind Phase II Trial of Cisplatin Plus Etoposide With/Without Concurrent ZD6474 in Patients With Previously Untreated Extensive Stage Small Cell Lung Cancer: Hoosier Oncology Group LUN06-113


OUTLINE: This is a multi-center study.

Arm A:

Cisplatin 60mg/m2 Day 1 + Etoposide 120mg/m2 Day 1,2,3 + Placebo oral daily given
continuously for the duration of the study

Arm B:

Cisplatin 60mg/m2 Day 1 + Etoposide 120mg/m2 Day 1,2,3 + ZD6474 100mg oral daily given
continuously for the duration of the study

For both arms, PE and toxicity evaluation prior to each cycle and disease assessment by
imaging every 2 cycles. Patients with non-PD and acceptable toxicity will continue protocol
therapy; patients with progressive disease or excessive toxicity will be taken off
treatment. Cycles will be repeated every 21 days up to a total of 4 cycles.

ECOG Performance Status of 0 or 1

Life Expectancy: Not specified

Hematopoietic:

- Platelets > 100K/mm3

- Absolute neutrophil count (ANC) > 1.5K/mm3

Hepatic:

- Bilirubin < 1.5 x ULN

- Aspartate aminotransferase (AST) < 2.5 x ULN or < 5 x ULN if judged by the
investigator to be related to liver metastases

- Alkaline phosphatase < 2.5 x ULN or < 5 x ULN if judged by the investigator to be
related to liver metastases

Renal:

- Serum creatinine < 1.5 x ULN or Calculated creatinine clearance of > 45 cc/min using
the Cockcroft-Gault formula

Cardiovascular:

- No clinically significant cardiac event such as myocardial infarction; New York Heart
Association (NYHA) classification of heart disease >2 (see SPM) within 3 months prior
to registration for protocol therapy

- No presence of cardiac disease that, in the opinion of the Investigator, increases the
risk of ventricular arrhythmia.

- No history of arrhythmia (multifocal premature ventricular contractions (PVCs),
bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation)
which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained
ventricular tachycardia. Atrial fibrillation, controlled on medication is permitted.


Inclusion Criteria:



- Histological or cytological proof of chemotherapy-naïve, extensive, small cell lung
cancer.

- Measurable disease according to RECIST and obtained by imaging within 28 days prior
to being registered for protocol therapy.

- Written informed consent and HIPAA authorization for release of personal health
information.

- Age 18 years or older at the time of consent.

- Potassium ≥4.0 mmol/L and <5.5mmol/L (supplementation is allowed).

- Calcium within normal range (supplementation is allowed).

- Magnesium within normal range (supplementation is allowed).

Exclusion Criteria:

- No prior EGFR inhibitor or antiangiogenic agent allowed.

- No prior hormonal therapy.

- No symptomatic brain metastasis.

- No clinically significant infections as judged by the treating investigator.

- No evidence of severe or uncontrolled other systemic disease or any concurrent
condition which in the Investigator's opinion makes it undesirable for the subject to
participate in the trial or which would jeopardize compliance with the protocol.

- No previous history of QTc prolongation as a result of medication that required
discontinuation of that medication.

- No congenital long QT syndrome or known 1st degree relative with unexplained sudden
death under 40 years of age.

- No presence of left bundle branch block (LBBB.)

- No QTc with Bazett's correction that is unmeasurable, or ≥480 msec on screening ECG
obtained within 7 days prior to registration for protocol therapy. If a subject has
QTc ≥480 msec on screening ECG, the screen ECG may be repeated twice (at least 24
hours apart). The average QTc from the three screening ECGs must be <480 msec in
order for the subject to be eligible for the study.

- No concomitant (within 14 days prior to registration for and during protocol therapy)
medication associated with Torsades de Pointes or cause QTc prolongation, is allowed.
Medications that prolong QT, but are not strictly associated with Torsades, are
allowed if medically necessary and will require increased ECG and electrolyte
monitoring.

- No uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or
diastolic blood pressure greater than 100 mm Hg).

- No currently active diarrhea that may affect the ability to absorb ZD6474.

- No prior malignancy is allowed except for adequately treated basal cell or squamous
cell skin cancer, in situ cervical cancer, Gleason < grade 7 prostate cancers, or
other cancer for which the subject has been disease-free for at least 5 years.

- Major surgery must be completed greater than 28 days prior to registration for
protocol therapy and healed surgical incision is required.

- No concomitant (within 14 days prior to registration for and during protocol therapy)
medications that are potent inducers (rifampicin, rifabutin, phenytoin,
carbamazepine, phenobarbital and St. John's Wort) of CYP3A4 function.

- Females of childbearing potential and males must be willing to use an effective
method of contraception (hormonal or barrier method of birth control; abstinence)
from the time consent is signed until 8 weeks after treatment discontinuation.

- Females of childbearing potential must have a negative pregnancy test within 7 days
prior to being registered for protocol therapy.

- Females must not be breastfeeding.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Outcome Measure:

The primary objective will be to evaluate whether the addition of ZD6474 to EP improves time to disease progression over EP alone.

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Nasser Hanna, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

LUN06-113

NCT ID:

NCT00613626

Start Date:

January 2008

Completion Date:

January 2014

Related Keywords:

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

Name

Location

Helen F. Graham Cancer CenterNewark, Delaware  19713
Providence Portland Medical CenterPortland, Oregon  97213-3635
Methodist Cancer CenterOmaha, Nebraska  68114
Northwestern University Feinberg School of MedicineChicago, Illinois  60611
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Medical & Surgical Specialists, LLCGalesburg, Illinois  61401
Cancer Care Center Of Southern IndianaBloomington, Indiana  47403
Oncology Hematology Associates of SW IndianaEvansville, Indiana  47714
Providence Medical GroupTerre Haute, Indiana  47802
Fort Wayne Oncology & Hematology, IncFort Wayne, Indiana  46815
Hematology Oncology Associates S.J., P.A.Mt. Holly, New Jersey  08060
Pennsylvania Oncology-Hematology AssociatesPhiladelphia, Pennsylvania  19106
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202
IN Onc/Hem AssociatesIndianapolis, Indiana  46202
St. Vincent Hospital & Health CentersIndianapolis, Indiana  46206
Monroe Medical AssociatesMunster, Indiana  46321
Horizon Oncology ResearcgLafayette, Indiana  47905
IU Health Arnett Cancer CenterLafayette, Indiana  47904
IU Health at Ball Memorial HospitalMuncie, Indiana  47303