Capecitabine and erlotinib in advanced lung cancer
| 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
Scientific
Royal Marsden NHS Foundation Trust
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom
Study information
| Study design | Phase 1b clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | 3+3 dose escalation design |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A phase 1b trial of the combination of CAPecItabine and Tarceva in Advanced Lung Cancer |
| Study acronym | CAPITAL |
| Study objectives | 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(s) | Regional Ethics Committee at the Royal Marsden NHS Foundation Trust, 16/10/2009, ref: 09/H0806/52 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | 1. Capecitabine (Xeloda) 2. Erlotinib (Tarceva) |
| Primary outcome measure | 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 study start date | 01/03/2010 |
| Completion date | 30/10/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 18/03/2010 |
| Date of final enrolment | 28/10/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Royal Marsden NHS Foundation Trust - Sutton
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom
Sutton
Surrey
SM2 5PT
United Kingdom
Royal Marsden NHS Foundation Trust
Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom
Chelsea
London
SW3 6JJ
United Kingdom
Sponsor information
Royal Marsden NHS Foundation Trust
Hospital/treatment centre
Hospital/treatment centre
Downs Road
Sutton
Surrey
SM2 5PT
England
United Kingdom
"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 share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | To 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.
