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

This study has been completed.
Sponsor:
Collaborator:
Weleda AG
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00516022
First received: August 13, 2007
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Mistletoe extract
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mistletoe as Complementary Treatment in Patients With Advanced Non-small-cell Lung Cancer (NSCLC), Treated With Carboplatin/Gemcitabine Chemotherapy Combination: Randomized Phase II Study

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Quality Of Life [ Time Frame: During the trial ] [ Designated as safety issue: No ]
    To check the effect of the treatment(or lack of it) on the quality of life of the patients enrolled to the trial.

  • Improvement in QOL. Improvement in the toxicity profile of the chemotherapy treatment [ Time Frame: During all the trial ] [ Designated as safety issue: Yes ]
    To check on the difference in QoL of all patients.


Secondary Outcome Measures:
  • Objective Response [ Time Frame: During all the duration of the trial ] [ Designated as safety issue: No ]
    The patients are asked to answer questions and the doctor will check blood works resolts.

  • Improvement in time to tumor progression (TTP) and survival Safety profile of mistletoe extract with combination of chemotherapy treatment [ Time Frame: During duration of all the trial ] [ Designated as safety issue: Yes ]
    Looking out for difference in toxicity profile of all patients


Enrollment: 79
Study Start Date: April 2007
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigator product
The patients randomized to this arm will receive the IP injections at home 3 times a week (the patients will inject the IP themselves).
Drug: Mistletoe extract
The drug will be administered 3 times a week at home.
Other Name: There's no drug to be administered in the control group.
Control
The patients randomized to this arm will continue to receive chemotherapy as usual without further treatment (unless prescribed by the Doctor).
Drug: Mistletoe extract
The drug will be administered 3 times a week at home.
Other Name: There's no drug to be administered in the control group.

Detailed Description:

The study design is to include 90 subjects. All subjects are treated with the common chemotherapy treatment. 50 percent will be treated with Iscador as combination with their common chemotherapy regimen. Common chemotherapy regimen used for NSCLC: Carboplatin and Gemcitabine. All study participants will receive this same chemotherapy regimen. This chemotherapy treatment is given every 3 weeks for up to 6 treatment cycles. The first day of the first treatment cycle, the combination of both Carboplatin and Gemcitabine will be administered. After a week (day 8 of treatment cycle) only Gemcitabine will be administered. Drugs would be calculated according to patient's body mass, renal function and general appearance. Once the patient signed Informed Consent he is assigned randomly to be treated with/without the injections of Mistletoe (called "Iscador"). Patient will receive the study medication (Iscador) as an intravenous injection that can be self injected or injected by any other of the family. Injections would be administered with low dose at the first week of the first treatment cycle and then, dose would be escalated, so as to check high sensitivity to the drug. Dosage would include: 2 injections of 0.1 mg, 2 injections of 0.1 mg and 2 injections of 1 mg. After that, treatment would continue with dosage of 10 g once every 2 days.

Patients from both treatment arms would be asked to fill-out QOL questionnaires at every treatment cycle and at follow-up visit after.

Study Primary Objectives:

  1. Improvement in QOL
  2. Improvement in the toxicity profile of the chemotherapy treatment

Secondary Objectives:

  1. Improvement in time to tumor progression (TTP) and survival.
  2. Safety profile of mistletoe extract with combination of chemotherapy treatment

This is a single center study, randomized phase II, with patients with advanced NSCLC treated with carboplatin/gemcitabine chemotherapy combination.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516022

Locations
Israel
Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Weleda AG
Investigators
Principal Investigator: Gil Bar-Sela Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00516022     History of Changes
Other Study ID Numbers: Mistletoe.ctil
Study First Received: August 13, 2007
Last Updated: September 26, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 23, 2014