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Carcinoma, Non Small Cell LungPhase 2PhalcisNCT01088906

Study of Pemetrexed Plus Cisplatin as First-line Therapy in Patients With Advanced Non-squamous NSCLC

A Phase 2 study testing Pemetrexed/Cisplatin in people with Carcinoma, Non Small Cell Lung, run by Spanish Lung Cancer Group at 8 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a study of pemetrexed disodium plus cisplatin as first-line therapy in patients with advanced non-squamous cell lung cancer. This is a phase IIA pharmacogenomic trial. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non Small Cell Lung
What is being tested?
Pemetrexed/Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
8 sitesSpain
Study dates
Jan 2010to Apr 2014
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

  • Histologic or cytologic diagnosis of non-squamous NSCLC, that is not amenable to curative treatment with surgery or radiation therapy. This population encompasses advanced stage patients with select stage IIIB (with pleural or pericardial effusion) or stage IV disease. Histologic or cytologic documentation of recurrence is required in patients who were previously completely resected and now have progressive disease.
  • Tissue must be available to generate and apply the genomics predictor. If not obtained at the time of diagnosis, then subject must consent to another biopsy. If patient had prior radiation therapy, tissue biopsy for genomics analysis must be outside radiation field.
  • At least one, non-radiated, measurable lesion by RECIST criteria.
  • ECOG performance status of 0 or 1
  • No prior chemotherapy, biologic or targeted therapy for any malignancy.
  • Prior radiation therapy is permitted if ≥1 week since completion of radiation treatment. Radiation must be <25% of bone marrow reserve.
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  • Age greater than 18 years.
  • No previous or concomitant malignancy in the past 5 years other than surgical management for carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin.
  • No other serious medical or psychiatric illness.
  • Signed informed consent.
  • Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post menopause) must test negative for pregnancy within 7 days prior to or at the time of enrollment based on a serum pregnancy test. Both sexually active males and females of reproductive potential must agree to use a reliable method of birth control, as determined by the patient and their health care team, during the study and for 3 months following the last dose of study drug.
  • Required laboratory data within two weeks of enrollment:
  • ANC or AGC greater than 1500 per uL
  • Platelets greater than 100,000 per uL
  • Total bilirubin less than 1.5mg/dL
  • Creatinine clearance greater than or equal to 45 ml/min.
  • SGOT/SGPT less than or equal to 3x/ULN except in presence of known hepatic metastases in which it may be up to 5x ULN.

Who cannot join

  • Patients with squamous cell NSCLC.
  • Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Concurrent administration of any other anti-tumor therapy.
  • Inability to comply with protocol or study procedures.
  • Active infection requiring IV antibiotics, antifungal or antiviral agents, that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
  • Documented symptomatic or untreated central nervous system (CNS) metastases (except if adequately treated and stable for at least 2 weeks).
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  • Major surgery within 2 weeks of study or other serious concomitant systemic disorders that, in the opinion or the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
  • Myocardial infarction having occurred less than 6 months before inclusion, any known uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia or cardiac failure not controlled by medications.
  • Have peripheral neuropathy of CTCAE Grade 1 or higher
  • Contraindications to corticosteroids.
  • Inability or unwillingness to take folic acid or vitamin B12 supplementation.
  • Unwillingness to stop taking herbal supplements while on study.
  • Presence of clinically significant third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study entry and throughout study enrollment as the distribution of pemetrexed in this fluid space is not fully understood.
  • Recent (within 30 days before enrollment) or concurrent yellow fever vaccination.
  • Have prior known allergic/hypersensitivity reaction to any of the components of study treatment
  • Inability to discontinue administration of aspirin at a dose greater than 1300 mg/day or other non-steroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days for long-acting agents such as piroxicam).
  • Female patients that is pregnant or breast-feeding.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Spain8 sites

  • H. Germans Trias i Pujol

    Badalona, Barcelona, 088916

  • H. Clínica Benidorm

    Benidorm, Alicante, 03501

  • H. General de Elche

    Elche, Alicante, 03202

  • Hospital Insular de Gran Canarias

    Las Palmas de Gran Canaria, Las Palmas, 35016

  • MD Anderson

    Madrid, 28033

  • Hospital 12 de Octubre

    Madrid, 28041

  • H. Morales Messeguer

    Murcia, 30008

  • H. Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320

Other trials in Spain

About this study

Official title: Study of Pemetrexed Disodium Plus Cisplatin as First-line Therapy in Patients With Advanced Non-squamous Cell Lung Cancer: a Phase IIA Pharmacogenomic Trial

This is a study of pemetrexed disodium plus cisplatin as first-line therapy in patients with advanced non-squamous cell lung cancer. This is a phase IIA pharmacogenomic trial.

Read the detailed description

This is a non-randomized, phase IIA pharmacogenomic, open label, uncontrolled, efficacy study in patients with advanced non-squamous cell lung cancer as a first line therapy.

Being tested
Pemetrexed/Cisplatin
Keywords
Phalcis, BRCA1, RAP80, TS, First line, Non-squamous
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Pemetrexed/CisplatinDrug

    Also called The Tradename of pemetrexed is Alimta

    Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day.

Study groups in NCT01088906
Study groupRoleWhat they receive
1 ARMExperimentalpemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days
Receives: Drug: Pemetrexed/Cisplatin

What is being measured

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

  1. Objective Response Rate

    The percentage of patients who have experienced a tumor response since the start of treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Measured: From start of treatment to end of follow up, up to 24 months

Secondary outcomes (8)

  1. Overall Survival

    Overall survival is measured from the date of enrollment to the date of death from any cause

    Measured: From the date of enrollment until end of follow up, up to 24 months.

  2. Time to Progression

    This interval is measured in months from the date of entry into the study until the first date of the appearance of new metastatic lesions or objective progression of the disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: From the date of enrollment until end of follow up, up to 24 months.

  3. Time to Progression of Patients According the Results of Biomarker BRCA1

    This interval is measured from the date of entry into the study until the first date of the appearance of new metastatic lesions or objective progression of the disease for patients with biomarker BRCA1.

    Measured: From the date of enrollment until end of follow up, up to 24 months.

  4. Time to Progression of Patients According the Results of Biomarker RAP80

    This interval is measured from the date of entry into the study until the first date of the appearance of new metastatic lesions or objective progression of the disease.

    Measured: From the date of enrollment until end of follow up, up to 24 months.

  5. Time to Progression of Patients According the Results of Biomarker TS

    This interval is measured from the date of entry into the study until the first date of the appearance of new metastatic lesions or objective progression of the disease.

    Measured: From the date of enrollment until end of follow up, up to 24 months.

  6. Overall Survival of Patients According the Results of Biomarker BRCA1

    Overall survival is measured from the date of enrollment to the date of death from any cause

    Measured: From the date of enrollment until end of follow up, up to 24 months.

  7. Overall Survival of Patients According the Results of Biomarker RAP80

    Overall survival is measured from the date of enrollment to the date of death from any cause

    Measured: From the date of enrollment until end of follow up, up to 24 months.

  8. Overall Survival of Patients According the Results of Biomarker TS

    Overall survival is measured from the date of enrollment to the date of death from any cause.

    Measured: From the date of enrollment until end of follow up, up to 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 posted17 Mar 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionApr 2014
  4. Study completionApr 2014

Why it stopped: No safety reasons. Low recruitment.

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01088906
Sponsor's protocol ID
GECP09-01Phalcis
Other IDs
2009-011327-31, 2009
Acronym
Phalcis
Status last verified
Jul 2024
First submitted
15 Mar 2010
Last updated
15 Oct 2024
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemetrexed/Cisplatin in people with Carcinoma, Non Small Cell Lung, run by Spanish Lung Cancer Group at 8 sites in Spain.

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 17 inclusion and 17 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: stopped early, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain. 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?

Yes. Results are posted in the registry (first posted 15 Oct 2024). 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?

Objective Response Rate (time frame: From start of treatment to end of follow up, up to 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 NCT01088906.

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 15 Oct 2024.

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