Condition category
Cancer
Date applied
14/01/2015
Date assigned
23/01/2015
Last edited
01/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mary E. R. O'Brien

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2008-007317-79

ClinicalTrials.gov number

Protocol/serial number

CCR3176

Study information

Scientific title

A phase 1b trial of the combination of CAPecItabine and Tarceva in Advanced Lung Cancer

Acronym

CAPITAL

Study hypothesis

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.

Ethics approval

Regional Ethics Committee at the Royal Marsden NHS Foundation Trust, 16/10/2009, ref: 09/H0806/52

Study design

Phase 1b clinical trial

Primary study design

Interventional

Secondary study design

3+3 dose escalation design

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Metastatic non-small cell lung cancer with adenocarcinoma histology, in the second line setting.

Intervention

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.

Intervention type

Drug

Phase

Phase I

Drug names

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

01/03/2010

Overall trial end date

30/10/2014

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

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

18/03/2010

Recruitment end date

28/10/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Trial participating centre

Royal Marsden NHS Foundation Trust
Fulham Road Chelsea
London
SW3 6JJ
United Kingdom

Sponsor information

Organisation

Royal Marsden NHS Foundation Trust

Sponsor details

Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

F Hoffman-La Roche Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication summary

Publication citations

Additional files

Editorial Notes