Epoetin Alfa in Advanced Non-Small Cell Lung Cancer (EPO-CAN-20)

Sponsor

Ontario Clinical Oncology Group (OCOG) (Other)

Overall Status

Terminated

CT.gov ID

NCT00310232

Collaborator

Ortho Biotech Products, L.P. (Industry)

Enrollment

Locations

37.9

Duration (Months)

4.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The general objective of this study is to improve the Quality of Life (QoL) of selected patients with advanced carcinoma of the lung. The specific objective is to evaluate the effect of treatment with epoetin alfa (recombinant human erythropoietin) on anemia related QoL and anemia in non-small cell lung cancer patients with advanced stage disease and underlying anemia of malignancy.

Condition or Disease	Intervention/Treatment	Phase
Non-Small-Cell Lung Carcinoma Lung Cancer Anemia	Drug: Epoetin Alfa	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Randomized Trial of Epoetin Alfa in Patients With Advanced Non-Small Cell Carcinoma of the Lung (EPO-CAN-20)

Study Start Date :

Feb 1, 2001

Actual Study Completion Date :

Apr 1, 2004

Outcome Measures

Primary Outcome Measures

Change in anemia and fatigue related QoL at 12 weeks following randomization [12 weeks following randomization]

Secondary Outcome Measures

Overall QoL and domain-specific QoL scores [16 weeks following randomization]
hemoglobin and hematocrit levels [6 months from randomization]
number of transfusions [6 months from randomization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically confirmed non-small cell lung cancer (squamous cell, large cell, adenocarcinoma, or some combination of these), with clinical or pathological stage III or IV, or recurrent disease; and
Hemoglobin level at or below 120 g/L; and
At least 18 years of age;

Exclusion Criteria:

Systemic platinum-based chemotherapy for lung cancer during the previous two months or planned platinum-based chemotherapy within the next three months;
Patients previously treated with high dose thoracic radiation (>10 fractions), or surgery, without objective evidence of disease recurrence;
Planned high dose thoracic radiation therapy (>10 fractions);
A clinically active malignancy, other than the underlying lung cancer which is expected to influence QoL;
Expected survival of three months or less;
ECOG Performance status of 3 or 4 (see Appendix D);
Multiple CNS metastasis or a single CNS lesion that does not demonstrate radiographic stability (Screening CT of head required only if symptomatic, no radiographic follow-up of single resected lesions required);
Blood transfusions within the last 14 days;
Previous use of erythropoietin;
Anemia due to factors other than cancer / radiotherapy (e.g. hemolysis or gastrointestinal bleeding);
Evidence of untreated folate or vitamin B12 deficiency;
History of uncontrolled hypertension or diastolic blood pressure greater than 100 mm Hg;
History of seizure disorder;
Known hypersensitivity to mammalian cell-derived products, albumin or any component of the study drug;
Pregnancy, lactation or parturition within the previous 30 days;
Unwillingness or inability to complete the required QoL questionnaires;
Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful completion of questionnaires;
Geographically inaccessible for treatment or follow-up evaluations;
Currently enrolled in an ongoing therapeutic study;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tom Baker Cancer Centre	Calgary	Alberta	Canada	T2N 4N2
2	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
3	Cancer Care Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
4	St. John Regional Hospital	St. John	New Brunswick	Canada	E2L 4L2
5	Newfoundland Cancer Treatment & Research Foundation	St. John's	Newfoundland and Labrador	Canada	A1B 3V6
6	Nova Scotia Cancer Centre	Halifax	Nova Scotia	Canada	B3H 1V7
7	Hamilton Regional Cancer Centre (Juravinski)	Hamilton	Ontario	Canada	L8V 5C2
8	London Regional Cancer Centre	London	Ontario	Canada	N6A 4L6
9	Hotel Dieu Hospital	St. Catherines	Ontario	Canada	L2K 5K3
10	Northeastern Ontario Regional Cancer Centre	Sudbury	Ontario	Canada	P3E 5J1
11	Toronto East General Hospital	Toronto	Ontario	Canada	M4C 3E7
12	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario	Canada	M4N 3M5
13	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
14	Windsor Regional Cancer Centre	Windsor	Ontario	Canada	N8W 2X3
15	McGill University Clinical Trials Operations	Montreal	Quebec	Canada	H2W 1S6