A Study for Patients With Non-Squamous Non-Small Cell Lung Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Dietary Supplement: Vitamin B12; Drug: pemetrexed; Dietary Supplement: Folic Acid; Drug: dexamethasone; Dietary Supplement: Folic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00609518

H3E-CR-S111 (Other Identifier)

11652 (Registry Identifier)

Details and patient eligibility

About

Chemotherapy for patients with non-squamous non-small cell lung cancer. Patients are given folic acid, vitamin B12 and steroids, both before and during treatment, to reduce the side effects associated with pemetrexed. The aim is whether it is possible to simplify the folic acid and steroid schedule without increasing toxicity.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC) with locally advanced or metastatic disease (Stage IIIA, IIIB or IV)that is of non-squamous histology
• Patients must have failed only one prior chemotherapy regime and must be considered eligible for further chemotherapy following progression of their disease.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• Adequate organ function

Exclusion criteria

• Concurrent administration of any other anti-tumor therapy
• Other co-existing malignancies
• Pregnancy or breast feeding
• Serious concomitant disorders
• Inability or unwillingness to take folic acid or vitamin B12 supplementation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

111 participants in 2 patient groups

Standard Vitamin and Steroid Schedule + Pemetrexed

Active Comparator group

Description:

Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.

Treatment:

Drug: dexamethasone

Dietary Supplement: Folic acid

Drug: dexamethasone

Dietary Supplement: Vitamin B12

Drug: pemetrexed

Simplified Vitamin and Steroid Schedule + Pemetrexed

Experimental group

Description:

Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.

Treatment:

Drug: dexamethasone

Drug: dexamethasone

Dietary Supplement: Vitamin B12

Dietary Supplement: Folic Acid

Drug: pemetrexed