Study of Oral Vinorelbine and Erlotinib in Non-Small Cell Lung Cancer

NCT00702182 | Completed Phase 1

• 1 other identifier: EPCTG-VEP1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to define the schedule and dose of oral vinorelbine (Navelbine) to be used with erlotinib in non-small cell lung cancer.

Conditions

Non-Small Cell Lung Cancer

Keywords

Lung Cancer; Vinorelbine; Erlotinib; Phase 1

Outcome Measures

Primary Outcomes (1)

• Define the recommended dose of oral navelbine with erlotinib

  3 weeks

Study Arms (2)

Conventional Vinorelbine, Erlotinib

EXPERIMENTAL

Escalating doses of vinorelbine on Day 1 and Day 8 of 21 Day cycle; Erlotinib 100 mg OD

Drug: Vinorelbine (Navelbine); Drug: Erlotinib

Metronomic Vinorelbine, Erlotinib

EXPERIMENTAL

Escalating doses of vinorelbine TIW; erlotinib 100 mg OD

Drug: Vinorelbine (Navelbine); Drug: Erlotinib

Interventions

Vinorelbine (Navelbine) DRUG

Conventional Schedule Oral Vinorelbine on day 1 and day 8 of a 21 day schedule

Also known as: Navelbine

Conventional Vinorelbine, Erlotinib

Erlotinib DRUG

Daily Oral Erlotinib 100 mg

Also known as: Tarceva

Conventional Vinorelbine, Erlotinib; Metronomic Vinorelbine, Erlotinib

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed NSCLC
• At least one or two prior lines of chemotherapy for metastatic disease or locally advanced unresectable disease. There should be at least 4 weeks since prior chemotherapy or radiation therapy or 6 weeks if the last regimen included BCNU or mitomycin C
• Age \> 21 years.
• ECOG performance status \<2 (Karnofsky \>60%, see Appendix A).
• Life expectancy of greater than 3 months
• Patients must have normal organ and marrow function as defined below:
• leukocytes \>3,000/mcL
• absolute neutrophil count \>1,500/mcL
• platelets \>100,000/mcL
• total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SGPT) \<2.5 X institutional ULN
• creatinine within normal institutional limits OR
• creatinine clearance \>60 mL/min/1.73 m2
• The effects of Oral Vinorelbine on the developing human fetus are unknown. For this reason and because vinca alkaloids as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Patients may not be receiving any other investigational agents.
• Patients who have received previous vinorelbine or oral EGFR tyrosine kinase inhibitors
• Patients with progressive brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However patients are eligible if they have brain metastases that have been treated with whole brain radiotherapy and are stable and not on corticosteroids.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Oral Vinorelbine or other agents used in study.
• Prior and / or concomitant treatment with drugs known to induce or inhibit cytochrome P450 3A4, CYP1A1 \& CYP1A2 : phenytoin, carbamazepine, barbiturates, rifampicin, imidazole antifungals (such as ketoconazole, fluconazole, itraconazole, metronidazole), omeprazole and ritonavir
• Significant malabsorption syndrome or disease affecting the gastro-intestinal tract function
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnancy or breast feeding or women of child-bearing potential not using effective contraception,
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Oral Vinorelbine. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
• History of organ allograft
• Patients with evidence or history of bleeding diatheses or coagulopathy
• Serious, non-healing wound, ulcer, or bone fracture
• Because of interaction risk on CYP3A4, patients with concomitant treatments with vitamin K antagonists such as phenprocoumon or warfarin or heparin or heparinoids should be excluded

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Center Singapore

Singapore, 169610, Singapore

Location

Related Publications (1)

• Sutiman N, Zhang Z, Tan EH, Ang MK, Tan SW, Toh CK, Ng QS, Chowbay B, Lim WT. Phase I Study of Oral Vinorelbine in Combination with Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Using Two Different Schedules. PLoS One. 2016 May 2;11(5):e0154316. doi: 10.1371/journal.pone.0154316. eCollection 2016.

  PMID: 27135612 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Vinorelbine; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Quinazolines

Study Officials

• Wan-Teck Lim, MD

  National Cancer Center Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 20, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 19, 2012

Record last verified: 2012-10

Locations

SG (1)