Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Carcinoma

Small Cell Lung Carcinoma

Carcinoma, Small Cell

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Pemetrexed

Cisplatin

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Phase 1: 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)

Phase 2: 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles

pemetrexed

Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles

cisplatin

Phase 1 and Phase 2: 50-62 Gy, 25-31 days, cycles 2-4

radiation

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)

The purpose of this study is to determine the recommended dose of pemetrexed, cisplatin and radiotherapy in the treatment of patients with Small Cell Lung Cancer.

A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy

Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer

Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

Complete Response Rate was defined as the proportion of participants having a Complete Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions.

Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.

The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.

Overall survival was the duration from enrollment to death. For patients who were alive, overall survival was censored at the last contact.

Eli Lilly and Company

Chief Medical Officer

Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)

Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles

Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles

Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4

Pemetrexed + Cisplatin

Age, Categorical

Sex: Female, Male

Belgium

Netherlands

Region of Enrollment

The Study Phase 1 was stopped early based on interim results of another trial, showing inferior activity of pemetrexed/carboplatin compared to etoposide/carboplatin in extensive small cell lung cancer. The Study did not progress to Phase 2.

This trial was terminated during the Phase 1 portion of this Phase 1/2 trial and it was too early to assess the recommended dose for Phase 2, or to estimate the maximum tolerated dose (MTD).

Phase 1: Maximum Tolerated Dose

This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.

Phase 2: Overall Response Rate

This trial was terminated during the Phase 1 portion of this Phase 1/2 trial and was stopped too early to assess best overall response.

Spots Global Cancer Trial Database for A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy

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