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Small Cell Lung CancerPhase 2NCT00613626

Cisplatin + Etoposide +/- Concurrent ZD6474 in Previously Untreated Extensive Stage Small Cell Lung Cancer

A Phase 2 study testing Cisplatin, Etoposide and ZD6474 in people with Small Cell Lung Cancer, run by Hoosier Cancer Research Network at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

At this point in the treatment of extensive stage SCLC, we have reached a plateau in survival with conventional chemotherapy and newer regimens are greatly needed. It has been noted that patients with increased VEGF levels have a poorer prognosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Cisplatin, Etoposide and ZD6474
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
19 sitesUnited States
Study dates
Jan 2008to Aug 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Cancer Care Center of Southern Indiana

    Bloomington, Indiana, 47403

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • Oncology Hematology Associates of SW Indiana

    Evansville, Indiana, 47714

  • Fort Wayne Oncology & Hematology, Inc

    Fort Wayne, Indiana, 46815

  • Medical & Surgical Specialists, LLC

    Galesburg, Illinois, 61401

  • IN Onc/Hem Associates

    Indianapolis, Indiana, 46202

  • Indiana University Simon Cancer Center

    Indianapolis, Indiana, 46202

  • St. Vincent Hospital & Health Centers

    Indianapolis, Indiana, 46206

  • IU Health Arnett Cancer Center

    Lafayette, Indiana, 47904

  • Horizon Oncology Researcg

    Lafayette, Indiana, 47905

  • Hematology Oncology Associates S.J., P.A.

    Mount Holly, New Jersey, 08060

  • IU Health at Ball Memorial Hospital

    Muncie, Indiana, 47303

  • Monroe Medical Associates

    Munster, Indiana, 46321

  • Helen F. Graham Cancer Center

    Newark, Delaware, 19713

  • Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Pennsylvania Oncology-Hematology Associates

    Philadelphia, Pennsylvania, 19106

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

  • Providence Medical Group

    Terre Haute, Indiana, 47802

Other trials in United States

About this study

Official title: 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

At this point in the treatment of extensive stage SCLC, we have reached a plateau in survival with conventional chemotherapy and newer regimens are greatly needed. It has been noted that patients with increased VEGF levels have a poorer prognosis. Anti-angiogenic agents hold significant promise in the treatment of patients with extensive stage SCLC. ZD6474, a new inhibitor of the VEGFR-2, has shown favorable action in NSCLC.

Read the detailed description

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.
Being tested
Cisplatin, Etoposide, Placebo, ZD6474
Keywords
Extensive Stage, Untreated
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles

  • EtoposideDrug

    Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles

  • PlaceboDrug

    Matched placebo oral daily

  • ZD6474Drug

    ZD6474 100mg oral daily to be continued for the duration of the study.

Study groups in NCT00613626
Study groupRoleWhat they receive
Arm A: ZD6474 Matched PlaceboPlacebo comparatorSubjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Receives: Drug: Cisplatin; Drug: Etoposide; Drug: Placebo
Arm B: ZD6474Active comparatorSubjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Receives: Drug: Cisplatin; Drug: Etoposide; Drug: ZD6474
Safety Lead-InExperimentalSubjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. The safety lead-in will be conducted to determine the safety of the combination of ZD6474 and cisplation + etopiside. If this combination is found to be unsafe, no patients will be randomized in the Phase II portion of the trial. If the combination is deemed safe according to the protocol, participants from the safety lead-in cohort will not be included in the efficacy analysis.
Receives: Drug: Cisplatin; Drug: Etoposide; Drug: ZD6474

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Disease Progression - Median Time to Progression and Log-Rank Test

    Kaplan-Meier analysis comparing arm A to arm B. Median time to progression and log-rank test. Safety lead-in participants are not included in this analysis per protocol.

    Measured: 24 months

Secondary outcomes (5)

  1. Percentage of Participants With Grade 3/4 Hematologic and Non-Hematologic Toxicities

    Percentage of participants who experienced grade 3/4 hematologic and non-hematologic toxicities. Participants from Arm A were compared to subjects from Arm B + Safety Lead-In.

    Measured: 6 weeks (2 Cycles)

  2. Measure the Response Rate (CR + PR) in Each Arm

    Response assessments completed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST Therasse et al., 2000). Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: >=30% decrease in the sum of the longest diameter of target lesions.

    Measured: 24 months

  3. Measure Disease Control Rate (CR + PR+ SD) in Each Arm

    Response assessments completed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST Therasse et al., 2000). Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as: neither a partial response or progressive disease ( >=20% increase in the sum of the longest diameter of the target lesions).

    Measured: 24 months

  4. Measure Overall Survival for Each Arm

    Measured: 24 months

  5. Assess VEGF Polymorphisms and Correlate Subject Response

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00613626
Sponsor's protocol ID
LUN06-113
Status last verified
Feb 2020
First submitted
31 Jan 2008
Last updated
11 Feb 2020
Data monitoring committee
Yes

Publications

  • Rachel E. Sanborn, Jyoti D. Patel, Gregory A. Masters, Nagesh Jayaram, Anthony W. Stephens, Michael J. Guarino, Jamal Ghazi Misleh, Corinne E. Williams, Jingwei Wu, Nasser H. Hanna. A randomized double-blind phase II trial of platinum (P) plus etoposide (E) with or without concurrent ZD6474 (Z) in patients (pts) with previously untreated extensive-stage (ES) small cell lung cancer (SCLC): Hoosier Oncology Group LUN06-113. J Clin Oncol 32:5s, 2014 (suppl; abstr 7506)

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin, Etoposide and ZD6474 in people with Small Cell Lung Cancer, run by Hoosier Cancer Research Network at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Disease Progression - Median Time to Progression and Log-Rank Test (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00613626, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.

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