E2598 – Trial Results Summary for Patients

Title

Testing the Potential of Herceptin (Trastuzumab) in the Treatment of Advanced Non-Small-Cell Lung Cancer (A Phase II Trial)

Sponsor

Eastern Cooperative Oncology Group through the NCI-sponsored Cancer Cooperative Group Program

Purpose of the Study

To evaluate the safety of a drug called Herceptin combined with the drugs carboplatin and paclitaxel to treat non-small-cell lung cancer. HER2/neu is a protein found on the surface of some lung tumors and facilitates the growth of the cancer. This study tested carboplatin and paclitaxel, drugs used to treat non-small-cell lung cancer, plus Herceptin, a new drug which is known to be active against some types of cancer where HER2/neu is present. The study also evaluated the effectiveness and safety of the three-drug combination in treating non-small-cell lung cancer (NSCLC)

Results

The overall response rate (the percentage of patients whose tumor shrinks by more than 50 percent or disappears) was 24.5 percent. Survival rates were similar to previous studies where only the two-drugs were used. Overall one-year survival was 42 percent, with an estimated two-year survival of 14.7 percent. A small subset of patients with more of the HER2/neu protein responded better to the drugs than expected. The side effects seen using this combination of drugs were no worse than those observed in chemotherapy treatment with carboplatin and paclitaxel alone.

Conclusion

Phase III trials will be needed to further evaluate the role of Herceptin in treating advanced non-small cell lung cancer.

Start Date

August 1999

Stop Date

May 2000

Number of Participating Patients

56

Eligibility Requirements

Patients had advanced (stage IV or stage IIIB), non-small-cell lung cancer that was measurable. Tests indicated the presence of a substance called HER-2/neu in the tumors of all eligible participants. Patients received no prior chemotherapy and had no history of congestive heart failure or heart attack in the previous three months.

Study Design

Participants in this study received paclitaxel through a vein over three hours, followed by carboplatin, also given through a vein, over 30 minutes every three weeks. Herceptin, the drug being studied, was given weekly by injection in a vein. Every six weeks, patients were tested to see if their disease was responding to treatment. If the cancer stayed the same or shrank, treatment continued for six cycles (18 weeks); provision was made to continue Herceptin alone for up to a year after the chemotherapy had been stopped if the patient’s disease remained the same or improved with treatment. If tumors grew or the patient was unable to tolerate treatment, the study treatment was stopped and the patient was offered alternative treatment.

Side Effects

The most serious problems during the study included blood cell abnormalities and fever. A small number of patients had mild cardiac problems. Nausea, fatigue, body aches and sensory problems (numbness in the hands and feet) were mild to moderate and similar to those expected with carboplatin and paclitaxel alone.

Additional Information at ClinicalTrials.gov

NCT00896909