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Phase II Study of Pemetrexed Plus Cisplatin in the Treatment of Patients With Extensive Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Small Cell Lung Cancer

Thank you

Trial Information

Phase II Study of Pemetrexed Plus Cisplatin in the Treatment of Patients With Extensive Small Cell Lung Cancer


Inclusion Criteria:



- Histologic or cytologic diagnosis of Small Cell Lung Cancer (SCLC).

- Functional stage from 0 to 2 of the ECOG functional scale

- No previous systemic chemotherapy, immunotherapy or biologic therapy for SCLC.

- Previous bone marrow radiotherapy less than 25% is allowed.

- There must be at least one measurable lesion that complies with the solid tumor
response evaluation criteria.

- Appropriate organic function.

- Life expectancy estimated at 12 weeks minimum.

- Females must be surgically sterile, postmenopausal or follow approved medical
contraceptive methods during the treatment period and 6 months afterwards. Males must
be surgically sterile or use a contraceptive method during the treatment period and
during 6 months after treatment.

- The patient must be compliant and located close to the trial area for appropriate
follow-up.

- The patient or his/her legal representative must sign an informed consent document.

- Patients must be at least 18 years of age.

Exclusion Criteria:

- Having received treatment for the last 30 days with a drug that has not obtained
regulatory approval.

- Having participated in a previous pemetrexed trial.

- Mixed histologic diagnosis of SCLC and NSCLC.

- Concurrent illness.

- Having an active infection.

- Severe cardiac disease.

- Having received recently or concurrently a vaccine against yellow fever.

- Having suffered a previous malignant process other than SCLC.

- Central nervous system (CNS) metastases require concurrent corticoid therapy. Treated
and stable CNS metastases are allowed.

- Clinically relevant fluid accumulation in the third space.

- Significant weight loss (greater than or equal to 10%) within 6 weeks prior to trial
inclusion.

- Concurrent administration of any other anti-tumor treatment.

- Severe renal failure.

- Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDS)
agents.

- Inability or unwillingness to take folic acid and vitamin B12 supplements.

- Inability to take corticoids.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Response Rate

Outcome Time Frame:

baseline to measured progressive disease

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Spain: Spanish Agency of Medicines

Study ID:

11473

NCT ID:

NCT00475657

Start Date:

October 2007

Completion Date:

April 2008

Related Keywords:

  • Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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