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Gastric AdenocarcinomaPhase 2SPIGANCT01379807

Efficacy and Safety of Panitumumab Combined With Docetaxel and Cisplatin as a First-line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

A Phase 2 study testing panitumumab + docetaxel + cisplatino in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Grupo Gallego de Investigaciones Oncologicas at 9 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The clinical hypothesis of this study is that the addition of Panitumumab to the first line treatment combination of docetaxel plus cisplatin will provide benefit to patients with advanced gastric or gastroesophageal junction adenocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
panitumumab + docetaxel + cisplatino
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
9 sitesSpain
Study dates
Dec 2010to Dec 2015
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

  • Written informed consent Inclusion:
  • Age ≥ 18 years
  • Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with advanced unresectable or metastatic disease.
  • Measurable disease per the revised RECIST (Response Evaluation Criteria in Solid Tumor) Guidelines
  • ECOG performance score of 0 - 2
  • Within seven days prior to initiating study treatment:Haematology:Neutrophils ≥ 1.5x109, Platelets ≥ 100x10/ L, Hemoglobin ≥ 9g/dL. Hepatic functions: Total bilirubin ≤ 1.5 time the upper normal limit (UNL),ASAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases,ALAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases. Renal function: creatinine clearance ≥50 mL/min. Metabolic Function: Magnesium ≥ lower limit of normal, Calcium ≥ lower limit of normal.

Who cannot join

  • Prior chemotherapy or other anticancer therapy for advanced unresectable or metastatic disease (1st line)
  • Prior anti-EGFR antibody therapy (e.g. cetuximab) or treatment with small molecule EGFR inhibitors (e.g. erlotinib).
  • HER2-positive tumor (centrally assessed)
  • Past or current history (within the last 5 years prior to treatment start) of other malignancies except gastric cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible)
  • Current or prior history of central nervous system metastases
  • Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study
Show all 11Show fewer
  • Known hypersensitivity to any of the study drugs
  • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
  • History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
  • Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
  • Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Spain9 sites

  • Complejo Hospitalario Universitario de A Coruña

    A Coruña, La Coruña, 15006

  • Centro Oncológico de Galícia

    A Coruña, La Coruña, 15009

  • Hospital Arquitecto Mercide

    Ferrol, La Coruña, 15405

  • Hospital Universitario Lucus Augusti

    Lugo, Lugo, 27003

  • Complejo Hospitalario Ourense

    Ourense, Ourense, 32005

  • Hospital de Pontevedra

    Pontevedra, Pontevedra, 36002

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    Santiago de Compostela, La Coruña, 15706

  • Complejo Hospitalario Universitario de Vigo (Xeral Cies)

    Vigo, Pontevedra, 36204

  • Policlínica de Vigo S.A.

    Vigo, Pontevedra, 36211

Other trials in Spain

About this study

Official title: A Phase II Trial to Assess the Efficacy and Safety of Panitumumab Combined With Docetaxel and Cisplatin as a First-line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

The clinical hypothesis of this study is that the addition of Panitumumab to the first line treatment combination of docetaxel plus cisplatin will provide benefit to patients with advanced gastric or gastroesophageal junction adenocarcinoma.

Being tested
panitumumab + docetaxel + cisplatino

What participants receive

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

  • panitumumab + docetaxel + cisplatinoDrug

    Panitumumab, docetaxel and cisplatin combination treatment will be administered for 6 months or until disease progression (PD) according to investigator's criteria unacceptable toxicity or consent withdrawal.

Study groups in NCT01379807
Study groupRoleWhat they receive
panitumumab + docetaxel + cisplatinoExperimentalNot described
Receives: Drug: panitumumab + docetaxel + cisplatino

What is being measured

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

  1. Objective response rate

    To estimate the objective response rate in patients treated with docetaxel, cisplatin and panitumumab as first-line treatment in advanced gastric or gastroesophageal junction adenocarcinoma.

    Measured: 3 years

Secondary outcomes (10)

  1. Disease control rate

    Measured: 3 years

  2. Duration of response

    Measured: 3 years

  3. Time to response

    Measured: 3 years

  4. Time to progression

    Measured: 3 years

  5. Time to treatment failure

    Measured: 3 years

  6. Duration of stable disease

    Measured: 3 years

  7. Progression free survival

    Measured: 3 years

  8. Overall survival

    Measured: 3 years

  9. Safety profile

    To describe the safety profile of this combination therapy in the 1st-line setting including the incidence of AE's and changes in laboratory parameters.

    Measured: 3 years

  10. Exploratory Objectives

    To investigate the predictive potential of different biomarkers on efficacy and/or safety endpoints.

    Measured: 3 years

Timeline

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

  1. First posted23 Jun 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2014
  4. Study completionDec 2015 (estimated)

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01379807
Sponsor's protocol ID
GGIO-2010-01
Acronym
SPIGA
Status last verified
Apr 2011
First submitted
22 Jun 2011
Last updated
11 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing panitumumab + docetaxel + cisplatino in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Grupo Gallego de Investigaciones Oncologicas at 9 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

Results are not available in the source record.

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: 3 years). 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 NCT01379807.

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 Mar 2015.

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