Complementary Treatment of PG2 to Improve Clinical Benefit Response and Quality of Life in Fatigue

Sponsor

PhytoHealth Corporation (Industry)

Overall Status

Terminated

CT.gov ID

NCT00518869

Collaborator

(none)

210

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the efficacy and safety of PG2 as a complementary treatment to conventional chemotherapy among NSCLC patients. In reference to previous studies, "Clinical Benefit Response" and "Incidence of Grade III plus VI Neutropenia" will be used as the primary endpoints in this study. Clinical Benefit Response is a metric measurement including change in cancer or cancer treatment related "fatigue" which is related to chronic fatigue syndrome (CFS), change in karnofsky performance status and change in weight. The secondary endpoints include patient's global quality of life, and the blood c-reactive protein level which is related to weight change, tumor response, survival time, incidences of myelosuppression (including neutropenia, anemia and thrombocytopenia) and the related G-CSF and antibiotics consumption.

Condition or Disease	Intervention/Treatment	Phase
Quality of Life Fatigue Complementary	Drug: PG2	Phase 2/Phase 3

Detailed Description

This is a multi-center, double-blind, randomized and placebo-controlled study to evaluate complementary effect of PG2 in patients with advanced non-small-cell lung cancer under conventional chemotherapy. Patients with Stage IIIb-IV non-small-cell lung cancer will be screened by inclusion and exclusion criteria and only eligible patients will be enrolled into this study.

All enrolled patients will be randomized to PG2 or Placebo arm and will receive the cisplatin-based chemotherapy treatment (Cisplatin 75mg/m2 and Docetaxel 60mg/m2 on Day1) during the first three 21-day chemo-cycles. Chemo regimen modification is allowable, as usual, in case of disease progression or unacceptable toxicity (see Section 6). After randomization, each patient will be administered with PG2 or placebo for 4 days in the 1st week, 3 days in the 2nd week and 3 days in the 3rd week of each chemo-cycle for 3 cycles (Dosing Schedule in Section 6). Total 10 doses will be given in each cycle.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Actual Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group PG2 plus standard chemotherapies	Drug: PG2 500 mg PG2 / 500 ml normal saline IV infusion for 3 hours once daily for 4 doses in the 1st week, 3 doses in the 2nd week and 3 doses in the 3rd week of each chemo-cycle for three cycles. Total 10 doses will be given in each cycle even with skip days.
Placebo Comparator: Placeo group Placebo plus standard chemotherapies	Drug: PG2 500 mg PG2 / 500 ml normal saline IV infusion for 3 hours once daily for 4 doses in the 1st week, 3 doses in the 2nd week and 3 doses in the 3rd week of each chemo-cycle for three cycles. Total 10 doses will be given in each cycle even with skip days.

Arm

Intervention/Treatment

Experimental: Treatment group

PG2 plus standard chemotherapies

Drug: PG2

500 mg PG2 / 500 ml normal saline IV infusion for 3 hours once daily for 4 doses in the 1st week, 3 doses in the 2nd week and 3 doses in the 3rd week of each chemo-cycle for three cycles. Total 10 doses will be given in each cycle even with skip days.

Placebo Comparator: Placeo group

Placebo plus standard chemotherapies

Drug: PG2

Outcome Measures

Primary Outcome Measures

Clinical Benefit Response [within and between each chemo-cycle (21 days)]
Incidence of Grade III plus IV Neutropenia [within and between each chemo-cycle (21 days)]

Secondary Outcome Measures

Quality of Life Assessments [within and between each chemo-cycle (21 days)]
The blood c-reactive protein level which is related to weight change [within and between each chemo-cycle (21 days)]
Tumor Response [3 months]
Survival Time [one year]
Incidences of myelosuppression and the related G-CSF consumption and antibiotics consumption [within and beween each chemo-cycle (21 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed the informed consent form.
18 ~ 75 years old
Locally advanced or metastatic with inoperable stage IIIb-IV non-small-cell lung cancer.
Chemo/Radio naive patient
Karnofsky Performance Scores ≧ 70.
Adequate bone marrow reserve.
Adequate liver function.
Adequate renal function.
Women with childbearing potential are willing to take contraception measures through the whole treatment course.
Life expectancy ≧ 3 months
Patient must be willing and able to complete quality of life questionnaires.

Exclusion Criteria:

Female patients are pregnant or breast-feeding
Patients have brain metastases, stroke or major psychiatric disease.
Patients with uncontrolled systemic disease such as active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus.
Patients have enrolled or have not yet completed other investigational drug trials within 30 days before randomization.

Contacts and Locations

Locations

	Site	City	Country
1	Changhua Christian Hospital	Changhua	Taiwan
2	Chang-Gung Memorial Hospital - Kaoshiung	Kaoshiung	Taiwan
3	Kaoshiung Medical University Hospital	Kaoshiung	Taiwan
4	Chang-Gung Memorial Hospital, Linkou	Linkou	Taiwan
5	China Medical University Hospital	Taichung	Taiwan
6	Taichung Veterans General Hospital	Taichung	Taiwan
7	National Cheng-Kung University Hospital	Tainan	Taiwan
8	Mackay Memorial Hospital	Taipei	Taiwan
9	Taipei Veterans General Hospital	Taipei	Taiwan
10	Tri-Service General Hospital	Taipei	Taiwan