GIDO1201

GIDO (Grup d'investigació i divulgació oncológica)

Velazquez 7 - 3ª, Madrid, Spain, 28001

GIDO, GIDO, secretariado@gido.es

GIDO, GIDO , secretariado@gido.es

No

No

No

Final

29 Dec 2017

No

Yes

29 Sep 2017

No

To evaluate the safety of bevacizumab in combination with carboplatin and paclitaxel as first-line treatment in elderly patients (≥70 years) with non-small-cell lung cancer, in terms of grade 3-4 neutropenia.

This clinical trial was conducted in accordance with the protocol, the principles established in the current revised version of the Declaration of Helsinki on medical research in human subjects (59th WMA General Assembly, Seoul, Korea, 2008), and in accordance with applicable regulatory requirements, in particular the 1996 ICH Harmonised Tripartite Guidelines For Good Clinical Practice and Royal Decree 223/2004 regulating clinical trials with medicinal products in Spain at the time of study initiation, and incorporating all the specific provisions for application in the member states of European Directive 2001/20/EC on clinical trials on medicinal products for human use. By signing this protocol, the investigators agreed to follow the instructions and procedures described in the protocol and therefore to comply with the principles of GCP on which it is based. Each patient who was asked to participate in the study was given a written document called “Patient Information Sheet”, which contained the necessary relevant information about the nature of the study, the study objectives and procedures, the potential benefits and risks for the patient, and the guarantee to protect his/her data. In addition, this document stated the voluntary nature of participation of the patient in the study and indicated in a clear and unequivocal manner the possibility of refusing to participate and withdrawing his/her consent at any time and for any reason, without having to explain this decision, and without it affecting his/her treatment and subsequent medical follow-up or his/her relationship with the physician treating him/her. Prior to the conduct of this study and in compliance with Royal Decree 223/2004, the sponsor submitted the protocol and informed consent form along with the pertinent documentation to the reference Clinical Research Ethics Committee (CREC) for its evaluation and subsequent report.

28 Aug 2013

No

No

Spain: 27

27

27

0

0

0

0

0

0

0

27

0

Overall trial (overall period)

Not applicable

Bevacizumab

Concentrate for solution for infusion

Intracavernous use

Bevacizumab was administered by intravenous infusion at a dose of 7.5 mg/kg (per body weight) on day 1 of each 21-day cycle in combination with carboplatin and paclitaxel for 4-6 cycles (at the investigator’s discretion) of treatment. In the absence of disease progression or unacceptable toxicity, treatment was maintained with bevacizumab monotherapy until disease progression or unacceptable toxicity, which was administered on day 1 of each 21-day cycle.

Carboplatin

Concentrate for solution for infusion

Intravenous use

Carboplatin was administered by intravenous infusion on day 1 of each 21-day cycle for 4-6 cycles (at the investigator’s discretion) in combination with paclitaxel and bevacizumab. The dose of carboplatin (mg) was determined using the Calvert formula: Dose (mg) = target AUC (mg/mL x min) x [GFR mL/min + 25]. The target AUC was 4 mg/min/mL. The Calvert formula was not be used in patients who had previously received intensive treatment.

Paclitaxel

Concentrate for solution for infusion

Intravenous use

Paclitaxel was administered by intravenous infusion at a dose of 175 mg/m2 on day 1 of each 21-day cycle for 4-6 cycles (at the investigator’s discretion) in combination with carboplatin and bevacizumab. Doses of paclitaxel were based on calculation of the patient’s body surface area, according to measurements of the patient’s weight and height taken on each visit. Body surface area (BSA) had to be calculated using a standard nomogram.

Overall trial

Single arm

The primary endpoint of the study will be the rate of grade 3-4 neutropenia, defined according to the National Cancer Institute Common Terminology Criteria the National Cancer Institute Common Terminology Criteria version 4.0 (NCI-CTC v4.0). It will be assessed from the first administration of study treatment until 28 ± 3 days after completion/interruption of treatment.

Primary

Since August 2013 (start of recruitment) until study closure (at 12 months from inclusion of the last patient in the study).

Time elapsed from the start of treatment to the treatment to the date on which disease progression according to RECIST v1.1 criteria or death from any cause is documented. RECIST v1.1 criteria or death from any cause.

Secondary

Since August 2013 (start of recruitment) until study closure (at 12 months from inclusion of the last patient in the study).

Time elapsed from the start of treatment to the time of death of the patient, regardless of the length of time the patient received the study treatment and the cause of death. treatment and the cause of death, regardless of how long the patient received the study treatment and the cause of death.

Secondary

Since August 2013 (start of recruitment) until study closure (at 12 months from inclusion of the last patient in the study).

The objective response rate is defined as complete response (CR) + partial response (PR), according to the Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1). Therefore, tumor response will be assessed at the screening visit (within 28 days prior to study treatment administration). In the treatment phase, it will be evaluated in cycles 2 and 4 of the initial carboplatin combination In the initial carboplatin-paclitaxel-bevacizumab combination treatment phase; then, in the maintenance treatment phase with bevacizumab monotherapy, it will be evaluated every 3 cycles (63 days) until disease progression, unacceptable toxicity or premature abandonment for any cause. Subsequently, at the end-of-treatment visit (28 ± 3 days after completion/interruption of study medication) and at follow-up visits (every 3 months ± 3 weeks).

Secondary

Since August 2013 (start of recruitment) until study closure (at 12 months from inclusion of the last patient in the study).

Best confirmed response to treatment according to the Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1).

Secondary

Since August 2013 (start of recruitment) until study closure (at 12 months from inclusion of the last patient in the study).

Since August 2013 (start of recruitment) until study closure (at 12 months from inclusion of the last patient in the study).

It is the investigator's responsibility to report all AAGs in the CRD, whether observed by the investigator or spontaneously reported by the patient participating in the study, regardless of the relationship to the treatments. AAGs will also be reported immediately to the CRO by the investigator using the AAG Reporting Form.

24.1

Single arm