AzTrials
AzTrials

Lung CancerPhase 1/2NCT00869752

MK-0646, Etoposide, and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer

A Phase 1/2 study testing anti-IGF-1R recombinant monoclonal antibody MK-0646, cisplatin and etoposide in people with Lung Cancer, run by NCIC Clinical Trials Group at 3 sites in Canada.

Completed

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

Official record
Search all trials

Trial summary

RATIONALE: Monoclonal antibodies, such as MK-0646, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
anti-IGF-1R recombinant monoclonal antibody MK-0646, cisplatin and etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
3 sitesCanada
Study dates
16 Dec 2009to 4 Jul 2012
Phase
Phase 1/2
Are there results?
None posted in the registry

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed small cell lung cancer (SCLC)
  • Extensive stage disease that is incurable but amenable to treatment with platinum-based chemotherapy
  • Small cell and variant histologies allowed
  • No mixed tumors (i.e., small and large cell) or other neuroendocrine tumors of the lung
  • Clinically and/or radiologically documented measurable disease, defined as ≥ 1 unidimensionally measurable site of disease ≥ 20 mm by chest x-ray, ≥ 15 mm by CT scan (lymph nodes), or ≥ 10 mm by CT scan or physical exam
  • No uncontrolled or symptomatic CNS metastases
  • Patients who have completed radiotherapy or have undergone complete resection of CNS metastases are allowed provided they are on stable (non-increasing) or decreasing doses of corticosteroids

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 12 weeks
  • ECOG performance status 0-2
  • Absolute granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN (≤ 5 times ULN if documented liver metastases)
  • Serum creatinine ≤ ULN OR creatinine clearance ≥ 50 mL/min
  • Not pregnant or lactating
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after completion of study therapy
  • No other active cancer
  • No untreated and/or uncontrolled cardiovascular or other comorbid conditions
  • Patients with a significant cardiac history, even if controlled, should have a LVEF > 50%
  • No uncontrolled diabetes
  • Must be accessible for treatment and follow-up

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior cytotoxic chemotherapy or other IGF-1R targeting agents for SCLC
  • At least 3 weeks since prior radiotherapy to neurological sites
  • No prior radiotherapy to the lungs
  • Prior surgery allowed provided that wound healing has occurred
  • At least 14 days since prior major surgery
  • No other concurrent investigational agents or therapy
  • No other concurrent anticancer treatment
  • No concurrent radiotherapy

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Ottawa Health Research Institute - General Division

    Ottawa, Ontario, K1H 8L6

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase I-II Trial of MK-0646, a Monoclonal Antibody Against Insulin-Like Growth Factor-1 Receptor, in Combination With Etoposide and Cisplatin in Extensive Stage Small Cell Lung Cancer

RATIONALE: Monoclonal antibodies, such as MK-0646, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as etoposide and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I/II trial is studying the side effects and best dose of MK-0646 when given together with etoposide and cisplatin and to see how well it works in treating patients with extensive-stage small cell lung cancer.

Read the detailed description

OBJECTIVES:

  • To determine the recommended phase II dose of MK-0646 in combination with a standard etoposide and cisplatin chemotherapy regimen in patients with extensive stage small cell lung cancer. (phase I)
  • To assess the toxicity and tolerability of this regimen in these patients. (phases I and II)
  • To evaluate the preliminary efficacy of this regimen in these patients. (phase I)
  • To assess the efficacy of this regimen, in terms of objective response rate, as well as complete response rate in these patients. (phase II)
  • To assess progression-free survival and overall survival of patients treated with this regimen. (phase II)
  • To explore the predictive and prognostic impact of biomarkers in patients treated with this regimen. (phase II)

OUTLINE: This is a multicenter, phase I, dose-escalation study of MK-0646 followed by a phase II study.

Patients receive MK-0646 IV over 1 hour on days 1, 8, and 15 and cisplatin IV and etoposide IV once daily on days 1-3. Treatment repeats every 3 weeks for 4 to 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients with complete response (CR) or partial response (PR) may continue MK-0646 in the absence of disease progression, with temporary discontinuation while undergoing prophylactic cranial irradiation or thoracic radiotherapy.

Blood samples are collected at baseline (pre-dose) and periodically for biomarker and pharmacogenetic correlative studies. Blood samples are analyzed for changes in expression of IGF biomarkers (e.g., IGF-1, IGF-2 and IGF-PB), haplotype tagging analysis of the IGF-1R, and evaluation of the immunoglobulin G fragment C receptor polymorphisms.

After completion of study therapy, patients are followed at 4 weeks. Patients with responding disease (i.e., CR, PR, or stable disease) are followed every 3 months until relapse or progression.

Conditions
Lung Cancer
Being tested
anti-IGF-1R recombinant monoclonal antibody MK-0646, cisplatin, etoposide
Keywords
combined type small cell lung cancer, fusiform type small cell lung cancer, polygonal type small cell lung cancer, lymphocyte-like type small cell lung cancer, extensive stage small cell lung cancer
Medical subject headings
Lung Neoplasms

What participants receive

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

  • anti-IGF-1R recombinant monoclonal antibody MK-0646Biological

    MK-0646 should be given 1st followed within 30-60 minutes by cisplatin and then etoposide for cycles which include both MK-0646 and chemotherapy. Cycles are 21 days

  • cisplatinDrug

    MK-0646 should be given 1st followed within 30-60 minutes by cisplatin and then etoposide for cycles which include both MK-0646 and chemotherapy. Cycles are 21 days

  • etoposideDrug

    MK-0646 should be given 1st followed within 30-60 minutes by cisplatin and then etoposide for cycles which include both MK-0646 and chemotherapy. Cycles are 21 days

Study groups in NCT00869752
Study groupRoleWhat they receive
Arm 1ExperimentalMK-0646, a monoclonial antibody in combination with etoposide and cisplatin.
Receives: Biological: anti-IGF-1R recombinant monoclonal antibody MK-0646; Drug: cisplatin; Drug: etoposide

What is being measured

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

  1. Recommended phase II dose of MK-0646 in combination with standard etoposide and cisplatin chemotherapy

    Evaluate safety, tolerability in combination with standard chemotherapy.

    Measured: Each dose level

  2. Toxicity and tolerability according to NCI CTCAE v3.0

    Look at toxicity and tolerability of MK0646 in combination with standard therapy.

    Measured: Phase 1, each dose level and Phase II

  3. Preliminary efficacy

    Look for evidence of response

    Measured: Phase 1 dose levels, evey other cycle

  4. Objective response rate

    Determine objective response rate including complete response rate, progression free survival and overall survival.

    Measured: Phase II portion, every other cycle

  5. Predictive and prognostic impact of biomarkers

    Blood samples will be collected and analyzed for occurrence of human-anti-humanized antibody response to MK0646 as well as IGF-1R analysis.

    Measured: Each cycle

Timeline

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

  1. First posted26 Mar 2009 (estimated)
  2. Study start16 Dec 2009
  3. Primary completion15 Mar 2012
  4. Study completion4 Jul 2012

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00869752
Sponsor's protocol ID
I190
Other IDs
CAN-NCIC-IND190, CDR0000634447
Status last verified
Apr 2020
First submitted
25 Mar 2009
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • J Clin Oncol 30, 2012 (suppl; abstr 7093)

  • Ellis PM, Shepherd FA, Laurie SA, Goss GD, Olivo M, Powers J, Seymour L, Bradbury PA. NCIC CTG IND.190 phase I trial of dalotuzumab (MK-0646) in combination with cisplatin and etoposide in extensive-stage small-cell lung cancer. J Thorac Oncol. 2014 Mar;9(3):410-3. doi: 10.1097/JTO.0000000000000058.

    PubMed 24518092

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing anti-IGF-1R recombinant monoclonal antibody MK-0646, cisplatin and etoposide in people with Lung Cancer, run by NCIC Clinical Trials Group at 3 sites in Canada.

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

Who may be eligible to take part?

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 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Recommended phase II dose of MK-0646 in combination with standard etoposide and cisplatin chemotherapy (time frame: Each dose level). The study lists 5 primary outcomes in all. 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 NCT00869752, which also lists 2 linked publications.

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 4 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in