Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA NSCLC

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A single arm, open-label phase II is appropriate to evaluate the efficacy and safety of dose

• dense combination of paclitaxel with cisplatin supported by pegfilgrastim for neo-adjuvant chemotherapy in this patient population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central European Cooperative Oncology Group
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

Criteria

Inclusion Criteria:

• histologic or cytologic diagnosis of NSCLC

• Presence of clinical Stage IIA,IIB or IIA disease

• tumor amenable to curative surgical resection

• Patients with clinically measurable lesions will be enrolled in this study.

• No prior tumor therapy

• Performance status of 0-1 on ECOG Scale

• Patients compliance and geographic proximity that allow adequate follow-up.

• Medical fitness of patient, including respiratory function, adequate for radical NSCLC surgery.

Exclusion Criteria:

• Presence of clinical Stage IIIA disease, according to the revision by Mountain CF of American Joint Committee on Cancer.

• Treatment within the last 30 days with any investigational drug.

• Cocurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.

• Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.

• pregnancy/breast feeding

• Serious concomitant disorders that would compromise the safety of the patient or compromise the patients ability to complete the study, at the discretion of the investigator.

• poorly controlled diabetes mellitus

• Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.

• History of significant neurological or mental disorder, including seizures or dementia.