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A Phase II Study to Investigate the Efficacy and Safety of Sorafenib as Adjuvant Treatment Following Resection of Non-small Cell Lung Carcinoma (NSCLC) in Patients Not Eligible for Cisplatin-based Adjuvant Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

A Phase II Study to Investigate the Efficacy and Safety of Sorafenib as Adjuvant Treatment Following Resection of Non-small Cell Lung Carcinoma (NSCLC) in Patients Not Eligible for Cisplatin-based Adjuvant Chemotherapy


Inclusion Criteria:



- Patients with histologically confirmed diagnosis of NSCLC pathological stages I, II
or III A

- Patients must have completely resected disease and may not be treated with prior
chemotherapy. Patients must have fully recovered from surgery prior to initiation of
study treatment.

- Adjuvant radiotherapy for stage III A disease is permitted given that the patient has
recovered from all radiation-induced toxicities. In those patients, a complete
restaging will be performed prior to enrolment into the trial.

- Patients with completely resected NSCLC stage II or III A, who for medical reasons
are not eligible for adjuvant chemotherapy consisting of a standard regimen of 4
cycles cisplatin/vinorelbine

- Patients with completely resected NSCLC stage II or III A, who are not willing to
undergo adjuvant chemotherapy with 4 cycles of cisplatin/ vinorelbine, are also
eligible.

- Age ≥ 18 years

- ECOG performance status ≤ 2

- Normal organ and marrow function defined as:

Hematopoetic: absolute neutrophil count >1,500/mm3, platelet count > 100,000/mm3,
hemoglobin > 9 g/dL INR < 1.5 ULN and PTT within normal limits Hepatic: total bilirubin <
1.5 x ULN, AST or ALT < 2.5 x ULN Renal: creatinine < 1.5 x ULN

- Women of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to the start of treatment

- Women of childbearing potential and men must agree to use adequate birth
contraception prior to study entry and for the duration of study participation. Women
and men should use adequate birth control for at least 3 months after the last
administration of Sorafenib.

- Written informed consent

Exclusion Criteria:

- Any other histology (e.g. SCLC, carcinoid tumors) or disease stages other than I to
III A

- Patients who are eligible and willing to undergo a standard adjuvant chemotherapy
regimen (4 cycles of cisplatin/vinorelbine)

- Any prior systemic anticancer therapy including chemotherapy, targeted agents,
experimental therapy or biological therapy for NSCLC

- Cardiac disease: congestive heart failure > class II NYHA, patients must not have
unstable angina pectoris or new onset of angina pectoris or myocardial infarction
within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic
therapy

- Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic
pressure > 90 mm Hg, despite optimal therapy

- Known brain metastasis. Patients with symptoms should undergo CT scan/MRI of the
brain to exclude brain metastasis

- Active clinically serious infections > NCI-CTCAE Grade 2

- Thrombotic or embolic events including transient ischemic attacks within the past 6
months

- Hemorrhage/bleeding event ≥ NCI-CTCAE Grade 3 within 4 weeks before first dose of
study drug

- Serious non-healing wound, ulcer or bone fracture

- Evidence or history of bleeding diathesis or coagulopathy

- Therapeutic anticoagulation with Vitamin K antagonists such as warfarin,
phenprocoumon, or with heparins or heparinoids. Low dose warfarin/phenprocoumon is
permitted if INR is < 1.5. Low dose aspirin (300 mg/d) is permitted.

- Use of St John's Wort or rifampicin

- Major surgery, open biopsy or significant traumatic injury within 4 weeks before
first dose of study drug

- Known or suspected allergy to Sorafenib or any agent given in the course of this
trial

- Previous cancer that is distinct in primary site or histology from NSCLC except
cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or
any cancer curatively treated ≥ 3 years prior to study entry.

- Substance abuse, medical or psychological condition that may interfere with the
patient´s participation in the study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) clinical and radiological assessment of remission status (RECIST criteria)

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Martin Schuler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Innere Klinik (Tumorforschung), Westdeutsches Tumorzentrum, Universitätsklinikum Essen, Hufelandstrasse 55, 45122 Essen

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

SIRN-TOM1 KKS 2006-010

NCT ID:

NCT00532025

Start Date:

September 2007

Completion Date:

September 2008

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Sorafenib
  • NSCLC
  • Adjuvant Treatment
  • resected Non-Small Cell Lung Carcinoma
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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