Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT00486356
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed cancer, meeting 1 of the following criteria:
* Disease that has progressed on standard therapy
* Locally advanced but unresectable primary or recurrent solid tumor
* Metastatic disease, including previously untreated metastatic disease for which study regimen represents reasonable initial chemotherapy with palliative intent (e.g., metastatic gastric cancer, hepatobiliary cancer, or cancer for which no effective standard therapy exists)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Absolute neutrophil count ≥ 2,000/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* alanine aminotransferase (ALT) \& aspartate aminotransferase (AST) ≤ 2.5 times ULN
* Creatinine ≤ 1.6 mg/dL
* Left ventricular ejection fraction ≥ 50%
* Fertile patients must use effective contraception
* Recovered from prior therapy
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) or immunotherapy
* At least 2 weeks since prior radiotherapy
* At least 8 weeks since prior strontium therapy
* At least 4 weeks since prior and no concurrent sorivudine or brivudine
Exclusion Criteria:
* No other potentially curative treatment options available (e.g., surgery, radiotherapy, chemoradiotherapy, or combination chemotherapy)
* No leukemia or lymphoma
* No primary central nervous system (CNS) malignancies or CNS metastases
* No other medical illness that would preclude study treatment
* No active infection requiring IV antibiotic therapy unless the infection has resolved
* No history of allergy to platinum compounds, mannitol, or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy
* No history of unexpectedly severe intolerance to fluorouracil
* Not pregnant or nursing/negative pregnancy test
* No prior doxorubicin at cumulative doses \> 300 mg/m²
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent cimetidine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00486356
Study Brief:
Protocol Section:
NCT00486356