CPCT-05 Biopsy Protocol Patient Selection

Solid Tumors Clinical Trial

Official title:

Protocol to Obtain Tumor Biopsies From Patients With Locally Advanced (Incurable) or Metastatic Cancer to Improve Selection for Clinical Trials. (CPCT - 05 Biopsy Protocol Patient Selection)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01904916
• Other study ID #: NL.45677.041.13
• Status: Terminated
• Phase: N/A
• First received: July 17, 2013
• Last updated: March 7, 2018
• Start date: January 2014
• Est. completion date: March 2017

Study information

• Verified date: March 2018
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our knowledge on the genetic mutations in cancer is rapidly expanding and we are increasingly testing drugs in mainly metastatic cancer patient populations with rare mutations. Successful examples of this new strategy are ALK inhibitors in ALK translocated NSCLC (less than 5% frequency) and EGFR inhibitors in EGFR mutant NSCLC (approximately 5% frequency). Selecting molecularly stratified patient populations for studies benefits the patient as it increases the odds of obtaining benefit from experimental treatment, especially in early clinical trials. Moreover it increases the speed and efficacy of drug development as signs of efficacy are picked up in earlier phases. Therefore, broad screening of molecular lesions in the tumors of patients that are being considered for participation in trials is crucial. This pre-selection increases our ability to perform several trials in parallel and thus include more patients in more meaningful trials. With the still dismal prognosis of patients with metastatic cancer, increasing the accrual rate to pivotal trials in selected patient populations is a key factor in improving prognosis.

The advent of Next Generation Sequencing (NGS) platforms enables us to probe a limited number of cancer related genes within 2-4 weeks. We have extensively piloted this approach and are now able to deliver clinically meaningful turn-around-times. This development enables us to use this technology to enrich clinical trials using targeted therapies for patients with specific mutations.

We will obtain tumor biopsies of a metastatic or locally advanced lesion and a peripheral blood sample from all patients included in the trial; the biopsies to obtain information on the tumor related genetic mutations (mutational profile) and the blood samples to assess each patient's germline DNA background variation. As patients will be asked to undergo an invasive procedure it is important to address the potential safety issues. Review of the literature and our own experience show that tumor biopsies can be performed with only minor complications and acceptable risks. We will recruit patients with metastatic or locally advanced solid tumors from patients that can potentially be included in clinical trials.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 195
• Est. completion date: March 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Locally advanced (incurable) or metastatic cancer from a histological or cytological proven solid tumor

• Indication for systemic treatment with anti-cancer agents (with no treatment options with curative intent)

• Measurable locally advanced (incurable) or metastatic lesion(s), according to RECIST 1.1 criteria.

• Safe biopsy of a metastatic or locally advanced lesion possible

• No contraindications for lidocaine (or its derivatives) and/or midazolam and/or phentanyl

• Adequate organ function

• WHO performance status 0-2

• Age > 18 yr

• Expected adequacy to follow up

• Written informed consent

Exclusion Criteria:

• If one or more of the above mentioned inclusion criteria is not met

Related Conditions & MeSH terms

• Metastatic Disease
• Neoplasm Metastasis
• Solid Tumors

Intervention

Procedure:
• Histological biopsy procedure

Locations

Country	Name	City	State
Netherlands	Antoni van Leeuwenhoek Ziekenhuis	Amsterdam
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
P.O. Witteveen	Erasmus Medical Center, The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of screened patients allocated to trials based upon outcome of genetic screening effort.		1 year
Secondary	Number and nature of (serious) adverse events of the performed histological biopsies.		2 days after each biopsy procedure
Secondary	Number of samples stored for future related research.		1 year
Secondary	Number of samples with an adequate microRNA, (phospho)proteomic profiles and organoid cultures that allows biomarker discovery efforts. These profiles will be deposited in the CPCT database.		1 year