Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Active-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
Brief Summary: The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.


Options:
A: Inclusion Criteria:

MDS defined as

* RCMD, RA with or without ring sideroblasts
* RAEB 1, or CMML 1, if WBC \< 13 G /l according to the WHO classification
* with a low or int-1 IPSS score AND
* primary or secondary resistance to epoetin alpha/ beta (\> 60000 U/w) or darbepoetin (\> 250ug/w), administered for at least 12 weeks
* requirement of RBC transfusions \> 4 U in the previous 8 weeks
* Aged 18 years or more
* Adequate contraception, if relevant
* Negative pregnancy test if relevant
* Written Informed consent
* Ability to participate to a clinical trial and adhere to study procedures
* Health insurance

Exclusion Criteria:

* Therapy-related MDS (after chemo- or radiotherapy for a previous neoplasm or immune disorder)
* Patients with a planned allogeneic bone marrow transplantation
* Creatininemia \>1.5 upper normal value or estimated Ccr less than 30ml/mn
* ALAT and ASAT \>2.5 upper normal value
* Bilirubin \>2N, except unconjugated hyperbilirubinemia due to MDS-related dyserythropoiesis
* Heart failure NYHA \> II
* Known allergy to mannitol
* Other tumor, unstable for the last three years, except in situ uterine carcinoma or basal skin tumor
* ECOG \> 2
* Life expectancy less than 3 months
B: Inclusion Criteria:

- Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol

Exclusion Criteria:

* Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy
* Subjects who have other diagnoses not related to the cancer which can cause anemia
* Known history of seizure disorder
* Cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment
* Subject of reproductive potential who is not using adequate contraceptive precautions
* Concerns for subject's compliance with the protocol procedures
C: Inclusion Criteria:

* subjects with non-myeloid malignancies
* anemia due to cancer
* ECOG status 0 to 2
* greater than or equal to 4-month expectancy
* greater than or equal to 18 years and of legal age for informed consent
* screening hemoglobin concentration less than or equal to 11.0g/dL
* adequate serum folate and vitamin B12
* adequate renal and liver function
* written informed consent

Exclusion Criteria:

* subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy during the study or within 4 weeks before randomization
* in complete remission, as determined by the investigator
* subjects who have other diagnoses not related to the cancer which cause anemia (eg. gastrointestinal bleeding, renal disease, etc)
* documented history of pure red cell aplasia
* Known history of seizure disorder
* cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
* uncontrolled hypertension
* clinically significant systemic infection or chronic inflammatory disease present at the time of randomization
* iron deficiency
* known positive test for HIV infection
* previously suspected of or confirmed to have neutralizing antibodies to rHuEPO or darbepoetin alfa
* received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization
* less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority
* pregnant or breast feeding
* subject of reproductive potential who is not using adequate contraceptive precautions
* known hypersensitivity to mammalian-derived product or any other ingredients in the investigational product
* previously randomized into this study
* concerns for subject's compliance with the protocol procedures
D: Inclusion Criteria:

* Non-myeloid malignancy
* At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
* Eastern Cooperative Oncology Group performance status of 0-2
* Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization
* Of legal age at the time written informed consent is obtained

Exclusion Criteria:

* Known history of seizure disorder
* Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy
* Unstable or uncontrolled disease/condition, related to or affecting cardiac function
* Clinically significant inflammatory disease
* Inadequate renal and/or liver function
* Known positive HIV test
* Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
* Received more than 2 red blood cell (RBC) transfusions within 4 weeks before randomization or any RBC transfusion within 14 days before randomization, or any planned RBC transfusion between randomization and study day 1
* Received any erythropoietic therapy within 4 weeks before randomization or any planned erythropoietic therapy between randomization and study day 1
* Other investigational procedures
* Subject is currently enrolled in or less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority
* Pregnant or breast feeding
* Not using adequate contraceptive precautions
* Known sensitivity to any of the products to be administered during dosing
* Previously randomized in this study
* Concerns for subject's compliance with protocol procedures

Answer: D