Mistletoe as Complementary Treatment in Patients With Advanced Non-small-cell Lung Cancer (NSCLC), Treated With Carboplatin/Gemcitabine Chemotherapy Combination.

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Mistletoe extract is one of the most common complementary treatments used in Europe. Recent basic studies reported tumor response and survival prolongation in number of treatments with Mistletoe preparations. There are evidence based data for using this drug as side effect reducer when use in combination with chemotherapy regimen treatment. Other clinical data, although not well based is that complementary treatment when used in combination with the common oncology treatment has tumor response effect. Combinations with platinum compound and a third generation cytotoxic agent have been accepted as 'standard of care' for patients with advanced NSCLC. The combination of platinum compound and one of the new agents are associated with response rates of 30-40% and a median survival of 8-11 months for advanced NSCLC patients with good performance status.

Study objective: Improvement in QOL, Improvement in the toxicity profile of the chemotherapy treatment.

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

Details

• Lead Sponsor: Rambam Health Care Campus
• Collaborator: Weleda AG
• Treatments: Carboplatin; Gemcitabine

Criteria

Inclusion Criteria:

1. Age above 18 years

2. Histology proven of NSCLC

3. Stage IIIB or IV (TNM classification)

4. Performance status < 2 (ECOG classification

5. Measurable disease with one or more disease sites measured by computed tomography (CT)

6. Life expectancy of more than 12 weeks.

7. Treatment combination of gemcitabine/carboplatin (GC)

8. Sign of written informed consent -

Exclusion Criteria:

1. Prior chemotherapy

2. Prior radiation- allowed as long as the treatment was not targeted only site of measurable disease and given more than 3 weeks before entry the trial.

3. Central nervous system metastases

4. Hypercalcemia

5. Other life threatening medical conditions

6. Patients not able to comply with s.c. injections