Chemotherapy and Radiotherapy to Treat Patients With Limited Stage of Small Cell Lung Cancer (SCLC)

Phase 2TerminatedNCT00494026

Eli Lilly and Company4 enrolled

Overview

This is a multicenter, phase II, open-label trial to evaluate the efficacy of pemetrexed + carboplatin combined with thoracic radiotherapy in patients with Limited Stage of small cell lung cancer

Two 21-day cycles of pemetrexed (500 milligrams per square meter \[mg/m2\] intravenous \[IV\] infusion) and carboplatin (target area under the curve \[AUC\] 5 IV infusion) followed by two 21-day cycles of pemetrexed (500 mg/m2 IV infusion) and carboplatin (target AUC 5 IV infusion) with concurrent radiotherapy (2 Gray \[Gy\] per fraction, 5 fractions per week, up to a dose of 50 Gy is administered).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Small Cell Lung Cancer

Interventions

pemetrexedDRUG

500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles

carboplatinDRUG

Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles

radiotherapyPROCEDURE

2 Gray (Gy) per fraction, 5 fractions per week, begin day 1, cycle 3 x 5 weeks (Monday-Friday)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologic and/or cytologic diagnosis of Limited Stage of small cell lung cancer * Measurable disease * Good performance status * Adequate bone marrow reserve, hepatic, pulmonary and renal functions Exclusion Criteria: * Serious concomitant systemic disorder * Prior chemotherapy for this cancer and/or prior thoracic radiotherapy * Pregnancy/breast-feeding * Significant weight loss over the previous 6 weeks before study entry * Inability or unwillingness to take vitamin supplementation and corticosteroids

Locations (12)

Outcomes

Primary Outcomes

Proportion of Patients With a Complete or Partial Response (Overall Response Rate [ORR])

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.

Time frame: baseline to measured response after chemotherapy and radiation

Secondary Outcomes

Progression-free Survival

Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.

Time frame: baseline to measured progressive disease

Overall Survival

Overall survival is the duration from enrollment to death (includes 1 year follow-up). For patients who are alive, overall survival is censored at the last contact.

Time frame: baseline to date of death from any cause, 1 year

Duration of Response

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.

Time frame: time of response to progressive disease

Pharmacology Toxicity

Radiation Therapy Oncology Group (RTOG) criteria were used for assessing toxicity. Toxicity grade reflected the most severe degree occurring during the evaluated period, not an average. When two criteria were available for similar toxicities, the one resulting in the more severe grade was used. Toxiccity grades range from 0 to 5. Toxicity grade = 5 if that toxicity caused the death of the patient.

Time frame: every 21-day cycle for 4 cycles

Data from ClinicalTrials.gov

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Orbassano, Italy

Parma, Italy

San Sisto, Italy

Terni, Italy

Poznan, Poland

Warsaw, Poland

Madrid, Spain

Palma de Mallorca, Spain

Valencia, Spain

Southampton, Hants, United Kingdom

...and 2 more locations