A phase 1b trial of the combination of CAPecItabine and Tarceva in Advanced Lung Cancer
That the combination capecitabine and erlotinib is safe, tolerable, and active in patients with metastatic non-small cell lung cancer, to be considered for further testing in phase 2 clinical trials.
Regional Ethics Committee at the Royal Marsden NHS Foundation Trust, 16/10/2009, ref: 09/H0806/52
Phase 1b clinical trial
Primary study design
Secondary study design
3+3 dose escalation design
Patient information sheet
Metastatic non-small cell lung cancer with adenocarcinoma histology, in the second line setting.
Escalating doses of capecitabine (mg/sq.m, p.o., b.i.d.) and erlotinib (mg, p.o., daily) will be given on a 3-weekly cycle.
1. Capecitabine (Xeloda)
2. Erlotinib (Tarceva)
Primary outcome measures
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
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.
Overall trial start date
Overall trial end date
Participant 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 ≥ 18yrs.
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
Target number of participants
It is expected that a maximum overall total of 40 patients will be enrolled (anticipated 28 to first part and 12 to second part).
Participant 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 breast-feeding
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Royal Marsden NHS Foundation Trust - Sutton
Downs Road Sutton
Trial participating centre
Royal Marsden NHS Foundation Trust
Fulham Road Chelsea
F Hoffman-La Roche Ltd (UK)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting