Pemetrexed and Platinum Use in the Neoadjuvant Setting for Resectable Stage II and IIIA Lung Adenocarcinoma

• Status: Unknown status
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is a prospective, single-center, open-label, single-armed, phase II clinical trial. The aim of the study is to evaluate the radiological response rate (RR) of 2 cycles of neoadjuvant chemotherapy with pemetrexed and cisplatin in patients with resectable stage II and IIIA lung adenocarcinoma.

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

Details

• Lead Sponsor: Fudan University
• Treatments: Cisplatin; Pemetrexed

Criteria

Inclusion Criteria:

1. Informed consent must be signed.

2. At least 18 years of age.

3. Histologically or cytologically diagnosed as lung adenocarcinoma.

4. Have measurable and clinical stage II-IIIA (excluding superior sulcus) disease eligible for surgery.

5. No previous systematic therapy or radiotherapy.

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

7. Have a predicted postresection forced expiratory volume in 1 second (FEV1) of ≧1.0 L.

8. Have adequate organ function including the following:

Bone marrow: absolute neutrophil count (ANC) ≥1.5*109/L, platelets ≥100*109/L, hemoglobin ≥8 g/dL.

Hepatic: bilirubin ≤1.5 ULN, alkaline phosphatase (AP), aspartate transaminase (AST), and alanine transaminase (ALT) ≤3.0 ULN.

Renal: calculated creatinine clearance ≥45 mL/min (using the standard Cockcroft-Gault formula).

9. For women: must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have negative serum or urine pregnancy test and must not be lactating. For men: must be surgically sterile, or compliant with a contraceptive regimen during and for 3 months after the treatment period.

Exclusion Criteria:

1. Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry or concurrent administration of any other anti-tumor therapy.

2. Clinically diagnosed as stage I or IIIB.

3. Have history of another malignancy within the last 5 years except cured carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and superficial bladder tumors [Ta, Tis & T1].

4. Concurrent use of any other anti-cancer therapy during study treatment.

5. Any unstable systemic disease (including active infection, hepatic, renal or metabolic disease) or serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.

6. Significant cardiovascular event: congestive heart failure > New York Heart Association (NYHA) class 2; unstable angina, active CAD (myocardial infarction more than 1 year prior to study entry is allowed); serious cardiac arrhythmia requiring anti-arrythmic therapy (beta-blockers or digoxin are permitted) or uncontrolled hypertension.

7. Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed. If a patient is taking an NSAID (Cox-2 inhibitors included) or salicylate with a long half-life (e.g. naproxen, piroxicam, diflusinal, nabumetone, rofecoxib, or celecoxib) it should not be taken 5 days before, the day of, and 2 days after the dose of pemetrexed.

8. Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.

9. Inability to comply with protocol or study procedures.

10. Pregnant or breast-feeding women and childbearing potential women with either a positive or no pregnancy test within 48 hours of the start of treatment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.