Capecitabine and erlotinib in advanced lung cancer

Phase 1

Completed

• Conditions: Metastatic non-small cell lung cancer with adenocarcinoma histology, in the second line setting; Cancer

• Registration Number: ISRCTN18199864
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-23
• Last Update Posted: 9 October 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Histologically confirmed diagnosis of NSCLC of adenocarcinoma sub-type. Mixed histological features are excluded
2. Progressing disease by radiological criteria
3. Any stage not fit for radical treatment
4. Age = 18 years
5. ECOG performance status 0-2 and predicted life expectancy = 12 weeks
6. Adequate haematopoietic, hepatic and renal function defined as follows: Absolute neutrophil count (ANC) =1.5 x 10^9/L and platelet count =100 x 10^9/L Bilirubin =1.5 x ULN, ALT (SGPT) =2.5 x ULN (or = 5 x ULN in cases of liver metastases) Serum creatinine clearance =50 ml/min
7. Patients must provide verbal and written informed consent to participate in the study
8. Use of an acceptable contraception for men and women of childbearing potential

For part 1 of the protocol (2nd-line patients), all the general inclusion criteria (above) must be met. In addition the following must be met:
1. Previous treatment with systemic chemotherapy (one line only for non-adjuvant / radical treatment)
2. Recovery from any treatment related toxicities regardless of regimen prior to registration, except for alopecia, grade 2 fatigue, or grade 1 neurotoxicity

For part 2 of the protocol (1st-line patients), all the general inclusion criteria must be met. In addition the following must be met:
1. Unsuitable for platinum-based doublet chemotherapy

Exclusion Criteria

1. Any concurrent anticancer systemic therapy
2. If the administration of erlotinib to patients receiving concomitant CYP3A4 or CYP1A2 inducers/inhibitors could impact significantly on their clinical care, these patients should be excluded- see Appendix 1
3. Prior treatment with any EGFR-directed inhibitor
4. Systemic chemotherapy, radiotherapy to a target lesion, or investigational anti-cancer treatment within 28 days of commencing treatment
5. Any other active malignancies unless deemed cured with at least 3 years of follow-up. In situ cervical cancer and in situ/basal cell skin cancer are permitted
6. Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient?s ongoing participation in the study
7. History of psychiatric condition that might impair the patient?s ability to understand or to comply with the requirements of the study or to provide informed consent
8. Gastro-intestinal abnormalities, including inability to take oral medication, requirement for intravenous feeding, active peptic ulcer, prior surgical procedures affecting absorption, any medical co-morbidity affecting gastrointestinal absorption
9. Patients on steroids must have been on that dose for at least 3 weeks
10. Pregnant women, or those currently breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the safety, tolerability and maximum tolerated dose of capecitabine when given in combination with erlotinib and to establish a dose limiting toxicity dose schedule for the combination.

Secondary Outcome Measures

Name	Time	Method
Preliminary assessment of the efficacy of capecitabine when given in combination with erlotinib. Efficacy will be measured by assessment of response rates, progression-free survival, and overall survival.