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Non Small Cell Lung CancerPhase 2IMPACTNCT00799240

MK-0646 Insulin Growth Factor 1 Receptor Antibody in Stage IIIb or IV Metastatic Non-Squamous Lung Cancer

A Phase 2 study testing Arm A: Pemetrexed Cisplatin and Arm B Pemetrexed, Cisplatin and MK-0646 in people with Non Small Cell Lung Cancer, run by University of Kansas at 4 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

This study will compare the rate of chemotherapy: pemetrexed and cisplatin compared with the combination of pemetrexed/cisplatin with MK-0646. The other purposes are to determine how long we can control the cancer growth and toxicity and safety of the combination. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Arm A: Pemetrexed Cisplatin and Arm B Pemetrexed, Cisplatin and MK-0646
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
4 sitesUnited States
Study dates
Jun 2009to Jul 2014
Phase
Phase 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

Who may be able to join

  • histologically or cytologically proven newly diagnosed Stage IlIB or Stage IV advanced primary non-small cell bronchogenic lung cancer (non-squamous cell to include bronchoalveolar, adenocarcinoma, large cell carcinoma, or unspecified).
  • clinically significant pleural effusion must have a thoracentesis.
  • Patients with brain metastases are eligible provided they have completed brain radiation, neurologically stable, off dexamethasone for at least 1 week prior to registration. Patients with asymptomatic brain metastatic disease are eligible if they do not require radiation and are neurologically stable without dexamethasone.
  • measurable disease documented by CT, MRI, X-ray or physical exam. Measurable disease must be assessed within 28 days prior to registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 28 days prior to registration. All disease must be assessed and documented.
  • Prior radiation is permitted; at least one week must have elapsed since the completion of prior radiation therapy and must have recovered from all associated toxicities at time of registration. Measurable or non-measurable disease must be outside the previous radiation field or a new lesion must be present.
  • At least 4 weeks have elapsed since surgery (thoracic or other major surgeries) and patients have recovered from all associated toxicities at the time of registration. Measurable disease must be present outside the area of surgical resection. There must be no anticipation of need for major surgical procedures during protocol treatment.
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  • Age ≥ 18 years old.
  • ECOG performance status of 0-1.
  • adequate bone marrow function defined by platelet count at least 100,000/mm3, hemoglobin ≥ 9g/dl, leukocyte count at least 3,000/mm OR absolute neutrophil count at least 1,500/mm3.
  • adequate hepatic function documented by serum bilirubin ≤ 1.5x upper normal limit, AST or ALT, and alkaline phosphatase all ≤ 3 x IULN within 28 days prior to registration. (Except in presence of known hepatic metastasis, wherein AST or ALT may be up to 5 X upper normal limit.)
  • serum creatinine ≤ institutional upper limit of normal (IULN) AND calculated or measured creatinine clearance ≥ 50 ml/mm using the Cockcroft Gault Formula. These tests must have been performed within 28 days prior to registration.
  • ability to give informed consent.
  • Able to provide consent for gene expression profiling, histopathology, and/or immunohistochemical assays
  • Women of childbearing potential must have negative serum pregnancy test.
  • Patients taking NSAIDs must agree to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed.
  • ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.

Who cannot join

  • Prior systemic chemotherapy or biologic therapy for non-small cell lung cancer. If neoadjuvant therapy or adjuvant therapy was given, patient must be at least 1 year out from the last chemotherapy and fully recovered from all toxicities.
  • Cardiovascular: uncontrolled congestive heart failure, high blood pressure, unstable angina, or myocardial infarction within the prior year,serious cardiac arrhythmias requiring medication.
  • Serious uncontrolled active infection, acute hepatitis or known HIV.
  • Prior history of severe allergy (grade 3 or 4) to human monoclonal antibody.
  • Concurrent use of human growth hormone or growth hormone inhibitors.
  • Uncontrolled diabetes mellitus defined as a Hemoglobin A1C≥ 7.
  • An other active malignancy in the past 2 years.
  • Pregnant or nursing women are not eligible to participate in this trial due to the potential teratogenic or abortifacient effects of the study drug on the fetus or nursing infant. Persons of reproductive potential must have agreed to use two methods of effective contraception prior to, during, and for 4 weeks after study therapy.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Hutchinson Clinic, PA

    Hutchinson, Kansas, 67502

  • Kansas University Cancer Center

    Kansas City, Kansas, 66160

  • VA Medical Center

    Kansas City, Missouri, 64128

  • Stormont Vail Healthcare

    Topeka, Kansas, 66606

Other trials in United States

About this study

Official title: MK-0646 IMPACT Study: MK-0646, Insulin Growth Factor 1 Receptor Antibody in Stage IIIB or IV Metastatic Non-Squamous Lung Cancer, Combined With Pemetrexed (Alimta) and Cisplatin, a Randomized Phase II Trial.

This study will compare the rate of chemotherapy: pemetrexed and cisplatin compared with the combination of pemetrexed/cisplatin with MK-0646. The other purposes are to determine how long we can control the cancer growth and toxicity and safety of the combination. Laboratory research with the tumor tissue and blood obtained will be done to assess IGF-1R expression and related markers and correlate with response and survival.

Read the detailed description

Insulin-like Growth factor 1 receptor (IGF-1R) is a tyrosine kinase receptor that regulates cell growth, proliferation and apoptosis.(4) Increased IGF1 signaling results in upregulation of proliferation and inhibition of apoptosis through RAF and PI3K pathways.(5) Several types of cancer, including non-small cell lung cancer, express IGF-1R and its ligand. The sequestration of IGF by IGF binding protein was associated with improved survival in patients with resected stage I lung cancer.(6) High expression of IGF-1R is associated with poor survival in surgically resected stage I lung cancer, specifically adenocarcinoma subtype. Patients with adenocarcinoma and never smoker had higher expression of IGF-1R vs. squamous cell carcinoma and smokers.(7). Low IGF-1R expression was associated with significant improvement in survival in the adenocarcinoma lung cancer but there was a lack of correlation between expression of IGF1R and survival in patients with squamous cell histology.

Monoclonal antibodies target the extracellular domain of IGF-IR and small molecules inhibit IGF-1R kinase. This is a potential new strategy in the treatment of lung cancer.

Being tested
Arm A: Pemetrexed Cisplatin, Arm B Pemetrexed, Cisplatin and MK-0646
Keywords
lung cancer, stage IIIb, pleural effusion, stage IV, metastatic lung cancer, non squamous lung cancer, IGF-1R, Pemetrexed, Cisplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Pleural Effusion, Insulin-Like Growth Factor I, Resistance To

What participants receive

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

  • Arm A: Pemetrexed CisplatinDrug

    Also called MK-0646

    Pemetrexed: 500mg/m2 IV on day 1 and Cisplatin: 75 mg/m2 IV on day 1 every 21 days x 6 cycles.

  • Arm B Pemetrexed, Cisplatin and MK-0646Drug

    Also called MK-0646

    Pemetrexed 500 mg/m2 IV on Day 1 and Cisplatin 75 mg/m2 IV on Day 1 every 21 days for 6 cycles in combination with MK-0646 will be given IV, 10 mg/KG, Days 1, 8 and 15 weekly.

Study groups in NCT00799240
Study groupRoleWhat they receive
Arm A Pemetrexed CisplatinActive comparatorArm A: Pemetrexed, cisplatin: pemetrexed and cisplatin chemotherapy at standard doses given IV every 21 days. Patients will be treated for a maximum of 6 cycles.
Receives: Drug: Arm A: Pemetrexed Cisplatin
Arm B Permetrexed, Cisplatin, MK-0646ExperimentalPemetrexed and cisplatin chemotherapy at standard doses given IV every 21 days in combination with MK-0646 given IV, 10 mg/Kg, Days 1, 8 and 15 weekly
Receives: Drug: Arm B Pemetrexed, Cisplatin and MK-0646

What is being measured

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

  1. Compare response rate between the two arms.

    Measured: 31 months

Secondary outcomes (2)

  1. Progression-free survival, overall survival and Toxicity profile

    Measured: 31 months

  2. Exploratory Objectives: Assess biomarkers of Pemetrexed, IGF-1R and immunogenicity of MK-0646.

    Measured: 31 months

Timeline

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

  1. First posted27 Nov 2008 (estimated)
  2. Study startJun 2009
  3. Primary completionFeb 2011
  4. Study completionJul 2014

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
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00799240
Sponsor's protocol ID
11386
Other IDs
MK-0646
Acronym
IMPACT
Status last verified
Dec 2013
First submitted
25 Nov 2008
Last updated
7 Nov 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Huang CH, Williamson SK, Neupane P, Taylor SA, Allen A, Smart NJ, Uypeckcuat AM, Spencer S, Wick J, Smith H, Van Veldhuizen PJ, Kelly K. Impact Study: MK-0646 (Dalotuzumab), Insulin Growth Factor 1 Receptor Antibody Combined with Pemetrexed and Cisplatin in Stage IV Metastatic Non-squamous Lung Cancer. Front Oncol. 2016 Jan 13;5:301. doi: 10.3389/fonc.2015.00301. eCollection 2015.

    PubMed 26793618

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Arm A: Pemetrexed Cisplatin and Arm B Pemetrexed, Cisplatin and MK-0646 in people with Non Small Cell Lung Cancer, run by University of Kansas at 4 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 16 inclusion and 8 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 7 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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. 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?

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?

Compare response rate between the two arms. (time frame: 31 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 NCT00799240, 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 7 Nov 2014.

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