Trials Sponsors Conditions Drugs Pricing

Conditions

Squamous Cell Carcinoma of the Esophagus

Keywords

Squamous Cell Carcinoma of the EsophagusRamucirumabPaclitaxel

Outcome Measures

Primary Outcomes (1)

Overall survival (OS) at 6 months
OS rate at 6 months, defined as patients who are alive after at 6 months
6 months

Secondary Outcomes (6)

Progression-free survival (PFS)
Up to 2 years
Overall survival
Up to 2 years
Objective response rate
Up to 2 years
Tumor control rate
Up to 2 years
Quality of life (QoL)
Up to 1 year and 30 days
+1 more secondary outcomes

Study Arms (2)

Arm A (Paclitaxel + Ramucirumab)

EXPERIMENTAL

Paclitaxel 80 mg/m2 as 1 hour intravenous infusion on day 1, 8, 15 plus Ramucirumab 8 mg/kg as 1 hour intravenous infusion on day 1 and 15 qd 28

Drug: RamucirumabDrug: Paclitaxel

Arm B (control arm)

ACTIVE COMPARATOR

Paclitaxel 80 mg/m2 as 1 hour intravenous infusion on day 1, 8, 15 qd 28

Drug: Paclitaxel

Interventions

RamucirumabDrug

Ramucirumab 8 mg/kg i.v. infusion on day 1 and 15

Also known as: Cyramza

Arm A (Paclitaxel + Ramucirumab)

PaclitaxelDrug

Paclitaxel 80 mg/m2 on day 1, 8, 15

Arm A (Paclitaxel + Ramucirumab)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed written informed consent;
Male or female\* ≥ 18 years of age; Patients in reproductive age must be willing to use adequate contraception during the study and for 6 months after the end of ramucirumab treatment (Appropriate contraception is defined as surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)). Female patients with childbearing potential need to have a negative pregnancy test within 7 days before study start.

Sponsors & Collaborators

Trium Analysis Online GmbH
Industrycollaborator
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Otherlead

Study Sites (2)

Institute for Clinical Cancer Research Krankenhaus Nordwest

Frankfurt, 60488, Germany

Technische Universität München Klinikum rechts der Isar

München, 81675, Germany

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

RamucirumabPaclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck Neoplasms

Study Officials

Salah-Eddin Al-Batran, Prof. Dr.
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
STUDY CHAIR

Enrollment

21 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 27, 2018

First Posted

December 3, 2018

Study Start

March 8, 2019

Actual (reported)

You may not qualify if:

Patients with significant malnutrition who receive intravenous hyperalimentation or require continuous infusion therapy with hospitalization.
Patients with apparent tumor invasion on organs located adjacent to the esophageal disease. Patients will be excluded if they are receiving stent therapy in esophagus or respiratory tract.
Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol.
Previous therapy with paclitaxeI
Current treatment with any anti-cancer therapy ≤ 2 weeks prior to study treatment start, unless rapidly progressing disease is measured
Concurrent treatment with any other anti-cancer therapy
Previous exposure to a VEGF or VEGFR inhibitor or any antiangiogenic agent, or prior enrolment in this study
Patient has undergone major surgery within 28 days prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 7 days prior to first dose of protocol therapy. The patient has elective or planned major surgery to be performed during the course of the clinical trial.
Grade 3-4 GI bleeding within 3 months prior to enrollment
History of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 3 months prior to first dose of protocol therapy-
Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.
Known brain or leptomeningeal metastases.
Known allergic/ hypersensitivity reaction to any of the components of the treatment.
Other serious illness or medical conditions within the last 12 months prior to study drug administration.
Any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to first dose of protocol.
+13 more criteria

Study With Paclitaxel +/- Ramucirumab in Patients With Squamous-cell Carcinoma of the Esophagus After Prior Therapy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Arm A (Paclitaxel + Ramucirumab)

Arm B (control arm)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Arm A (Paclitaxel + Ramucirumab)

Arm B (control arm)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations