Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (Relapsed After a Cisplatin Based Treatment)Phase 2NCT01262482

Study of Oxaliplatin and Sorafenib Combination to Treat Gastric Cancer Relapsed After a Cisplatin Based Treatment

A Phase 2 study testing Oxaliplatin and Sorafenib in people with Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (Relapsed After a Cisplatin Based Treatment), run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 10 sites in Spain.

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

In Spain, the gastric carcinoma is the 5th most frequent malignant tumor in women and the 6th in men, and represents the 3rd cause of cancer-related deaths amongst women and the 4th amongst men. The average of 5-year survival rate in Spain is under 30%. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (Relapsed After a Cisplatin Based Treatment)
What is being tested?: Oxaliplatin and Sorafenib
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 10 sitesSpain
Study dates: Oct 2008to Dec 2011
Phase: Phase 2

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

Gastric or gastroesophageal junction adenocarcinoma confirmed by cytology or biopsy, with unresectable or metastatic disease which have progressed to a cisplatin-fluoropyrimidine based scheme (excluded neoadjuvant treatment administered with or without concomitant radiotherapy)
Older than 18 years at the moment of informed consent form signature
Age > 18 years
ECOG 0-2
Measurable disease by RECIST criteria. Lesions have to be measured by CT-scan or MRI
Life expectancy > 12 weeks

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Adequate medullary reserve and hepatic and renal function, defined according to the following parameters:
Hemoglobin ≥ 9g/dl
Neutrophils ≥ 1,5 x 10^9/L
Platelets ≥100 x 10^9/L
Total bilirubin ≤ 1,5 times the upper limit of normal (ULN)
ALT (GTP) and AST (GOT) ≤ 2,5 times the upper limit of normal (ULN) (≤ 5 times the ULN in patients with hepatic metastasis)
PT-INR-PTT ≤ 1,5 times the ULN. (The patients under anticoagulant treatment with dicumarin or heparin can be included if there is no previous evidence of alteration in these parameters)
Creatinine clearance > 30ml/min
The patients have to be able to understand the meaning of their participation in the trial and voluntary give their participation consent signing the informed consent form

Who cannot join

More than one line for the treatment of locally advanced disease
Active ischemic cardiopathy. History of cardiac disease defined as follow:
Congestive cardiac failure > class 2 from the NYHA
Active coronary disease. The recruitment of patients with solved myocardial infarction is allowed, if diagnosed at least 6 months before the trial start
Cardiac arrhythmia requiring treatment with antiarrhythmic drugs. (The treatment with beta-adrenergic antagonists or digoxin is allowed)
Non-controlled arterial hypertension

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Non-controlled intercurrent illness
Symptomatic sensitive peripheral neuropathy
Another malignant disease diagnosed in the past 5 years, except in situ cervix carcinoma adequately treated, non-melanoma skin carcinoma, superficial bladder tumor (Ta, Tis and T1), or any tumor treated in a curative way until 3 years prior to the recruitment
Pregnant or breastfeeding women. Women will have to undergo a pregnancy test within 7 days prior to the recruitment. Both men and women recruited in the trial will have to use appropriate barrier contraceptive methods during their sexual relations during the trial period and at least until two weeks after its completion. Men participating in this trial will have to continue using this contraceptive methods at least until 3 months after the treatment completion
Chronic diseases: AIDS, Hepatitis B and/or Hepatitis C
Clinically active severe infection (Grade 2 NCI-CTC version 3.0)
Cerebral metastasis or meningeal tumor
Patients requiring chronic corticosteroid treatment or high doses of corticosteroids or any other immunosuppressive treatment
Patients having undergone a major surgery within the 4 weeks prior to the trial start
Patients having completed a chemotherapy or radiotherapy treatment within the 4 weeks prior to the clinical trial start (except palliative radiotherapy, within the 2-weeks prior to the clinical trial start)
Previous treatment using a RAS pathway inhibitor
Any medical or severe psychiatric condition or drug consumption involving a serious risk for the patient if taking part in the clinical trial or that can prevent the signature of the informed consent form
Patients unable to swallow medication

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Spain10 sites

Hospital Clinic de Barcelona
Barcelona
Hospital Sant Pau
Barcelona
H. Josep Trueta
Girona
Centro Oncológico M.D. Anderson Spain
Madrid
Hospital de Fuenlabrada
Madrid
Hospital La Paz
Madrid
Hospital Althaia
Manresa
Clínica Universitaria de Navarra
Pamplona
Hospital Parc Taulí
Sabadell
Hospital General de Valencia
Valencia

Other trials in Spain

About this study

Official title: A Phase 2 Trial of Oxaliplatin and Sorafenib Combination in Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, Relapsed After a Cisplatin Based Treatment

Sorafenib has been the first RAF inhibitor, both of RAF-1 and B-rRAF and its b-RAF variant V600E. Moreover, it has shown its ability to inhibit other tyrosin-quinase receptors as VEGFR 2 and 3, c-kit, Flt-3 or PDGFR. Its activity has been clearly proven in clear cell renal carcinoma.

The mechanism by which Sorafenib seems to act is not because of the existence of a mutation of RAS or RAF, but because as there is a VHL shortage the HIP produces a VEGF, bFGF or TGF overexpression that produces in turn a hyper-stimulation on the RAF/ERK/MEK pathway.

The RAF/MEK/ERK pathway and angiogenesis seem to be clearly involved in the gastric carcinoma tumorigenesis and progression. Because of that, it seems interesting to associate Sorafenib to an oxaliplatin-based chemotherapy, which has shown its effectiveness in relapsed patients after receiving cisplatin-based schemes. Moreover, there is a phase 1 trial confirming the tolerance of the oxaliplatin and Sorafenib association, describing partial responses amongst gastric cancer patients previously treated with cisplatin.

Conditions: Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (Relapsed After a Cisplatin Based Treatment)
Being tested: Oxaliplatin, Sorafenib
Keywords: adenocarcinoma, gastric, gastroesophageal junction, Relapsed, sorafenib, oxaliplatin
Medical subject headings: Adenocarcinoma, Recurrence

What participants receive

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

OxaliplatinDrug
130 mg/m2, IV during 2 hours on day 1 of each 21 day cycle. Number of cycles: until progression, intolerance or unacceptable toxicity develops, or until patient or investigator decide to stop the treatment.
SorafenibDrug
400mg, orally, 2 times per day. Until progression, intolerance or unacceptable toxicity develops, or until patient or investigator decide to stop the treatment.

Study groups in NCT01262482
Study group	Role	What they receive
Oxaliplatin + Sorafenib	Experimental	Not described Receives: Drug: Oxaliplatin; Drug: Sorafenib

What is being measured

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

Progression free survival
Measurements according to RECIST criteria (Response Evaluation Criteria in Solid Tumors). Main techniques: CT-scan and Magnetic Resonance Imaging (MRI)
Measured: anticipated 3 years

Secondary outcomes (4)

Tumoral response
Measurements according to RECIST criteria (Response Evaluation Criteria in Solid Tumors). Main techniques: CT-scan and Magnetic Resonance Imaging (MRI)
Measured: anticipated 3 years
Response duration
Duration of the partial or total response to the treatment. Evaluation and classification according to RECIST criteria (Response Evaluation Criteria in Solid Tumors)
Measured: anticipated 3 years
Overall survival
Measured: anticipated 3 years
Toxicity
Measured: anticipated 3 years

Timeline

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

Oct 2008Dec 2011

First posted17 Dec 2010 (estimated)
Study startOct 2008
Primary completionOct 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (Relapsed After a Cisplatin Based Treatment)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01262482
Sponsor's protocol ID: GEMCAD-0802
Other IDs: 2008-004223-27, 2008
Status last verified: Dec 2010
First submitted: 16 Dec 2010
Last updated: 9 Nov 2012
Results posted: No
Data monitoring committee: No