ISRCTN ISRCTN18199864
DOI https://doi.org/10.1186/ISRCTN18199864
EudraCT/CTIS number 2008-007317-79
Secondary identifying numbers CCR3176
Submission date
14/01/2015
Registration date
23/01/2015
Last edited
18/09/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mary E. R. O'Brien
Scientific

Royal Marsden NHS Foundation Trust
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom

Study information

Study designPhase 1b clinical trial
Primary study designInterventional
Secondary study design3+3 dose escalation design
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA phase 1b trial of the combination of CAPecItabine and Tarceva in Advanced Lung Cancer
Study acronymCAPITAL
Study objectivesThat 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.
Ethics approval(s)Regional Ethics Committee at the Royal Marsden NHS Foundation Trust, 16/10/2009, ref: 09/H0806/52
Health condition(s) or problem(s) studiedMetastatic non-small cell lung cancer with adenocarcinoma histology, in the second line setting
InterventionEscalating 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.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase I
Drug / device / biological / vaccine name(s)1. Capecitabine (Xeloda) 2. Erlotinib (Tarceva)
Primary outcome measureTo 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 measuresPreliminary 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 study start date01/03/2010
Completion date30/10/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsIt is expected that a maximum overall total of 40 patients will be enrolled (anticipated 28 to first part and 12 to second part)
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment18/03/2010
Date of final enrolment28/10/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Royal Marsden NHS Foundation Trust - Sutton
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom
Royal Marsden NHS Foundation Trust
Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom

Sponsor information

Royal Marsden NHS Foundation Trust
Hospital/treatment centre

Downs Road
Sutton
Surrey
SM2 5PT
England
United Kingdom

ROR logo "ROR" https://ror.org/0008wzh48

Funders

Funder type

Industry

F Hoffman-La Roche Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planTo be confirmed at a later date
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2016 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

18/09/2017: Publication reference added.