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A Phase II Trial With Pemetrexed Plus Cisplatin as First Line Chemotherapy for Advanced Non - Small Cell Lung Cancer (NSCLC) Patients With Measurable Asymptomatic Brain Metastasis (GFPC 07-01/METAL).

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase II Trial With Pemetrexed Plus Cisplatin as First Line Chemotherapy for Advanced Non - Small Cell Lung Cancer (NSCLC) Patients With Measurable Asymptomatic Brain Metastasis (GFPC 07-01/METAL).

Inclusion Criteria:

- Patients with cytologically or histologically confirmed NSCLC.

- Patient with brain metastasis not amenable to surgery or radiosurgery with curative

- At least one brain measurable lesion using RECIST criteria

- ECOG Performance Status ≤2

- No prior chemotherapy for this cancer

- Prior surgery is allowed provided there is a relapse or progression after the

- Adequate organ function including the following: Adequate bone marrow reserve:
absolute neutrophil count (ANC) superior or equal to 1.5 X109/L, platelets superior
or equal to 100 X 109/L, and hemoglobin superior or equal to 9 g/dL; Hepatic:
bilirubin <1.5 times the upper limit of normal (ULN), alkaline phosphatase (AP),
aspartate transaminase (AST) and alanine transaminase (ALT) <3xULN (or <5xULN with
liver metastases); Renal: Calculated creatinine clearance (CrCl) superior or equal to
45mL/min based on the standard Cockroft and Gault formula

- Signed informed consent document from the patient

- Patient must be at least 18 years of age.

- Estimated life expectancy of at least 12 weeks.

- Effective contraception (men and women) for and during the 6 months following the end
of treatment

Exclusion Criteria:

- Symptomatic brain metastasis

- Have received prior radiotherapy for brain metastasis

- Unable or unwilling to take folic acid, vitamin B12 supplementation or dexamethasone
(or equivalent corticosteroid); or any other inability to comply with protocol or
study related procedures.

- A prior malignancy other than NSCLC, except carcinoma in situ of the cervix or
non-melanoma skin cancer, adequately treated low grade [Gleason score <6] localized
prostate cancer, unless that prior malignancy was diagnosed and definitively treated
at least 5 years previously with no subsequent evidence of recurrence

- Serious concomitant systemic disorders (for example, active infection or abnormal
electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the
investigator, would compromise the safety of the patient and his/her ability to
complete study.

- Inability to discontinue administration of aspirin at a dose >1.3g/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 prior for long-acting agents such as piroxicam).

- Presence of fluid accumulations in third spaces, e.g., ascite or pleural effusion,
which can be detected clinically (during physical examination), and which cannot be
adequately controlled by drainage or other procedures prior to inclusion in the

- Peripheral neuropathy > CTC Grade 2

- Patient compliance or geographic distance precluding adequate follow up.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective of this study is overall response rate on brain metastasis according to RECIST criteria.

Outcome Time Frame:

After cycles 2, 4 and 6 and every 6 weeks after study drug completion in absence of disease progression.

Safety Issue:


Principal Investigator

Gilles Robinet, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Brest


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GFPC 07-01



Start Date:

September 2008

Completion Date:

Related Keywords:

  • Lung Cancer
  • Pemetrexed, Non-Small Cell Lung Cancer, brain metastasis
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Brain Neoplasms