Clinical trial · Interventional
T900607 in Treating Patients With Unresectable Liver Cancer
A Phase II Study Of Intravenous T900607-Sodium In Subjects With Chemotherapy-Naive Unresectable Hepatocellular Carcinoma
NCT00054262CI-TRIAL-00011429completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of T900607 in treating patients who have unresectable liver cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| T900607 | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed unresectable hepatocellular carcinoma (HCC) * Bidimensionally measurable disease defined as at least 1 lesion that is 1 cm or more in 2 dimensions by CT scan * Class A or B Child-Pugh liver classification * No prior CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3\* * Platelet count at least 100,000/mm\^3\* * Hemoglobin at least 8.5 g/dL\* NOTE: \*More than 7 days since prior blood transfusions or growth factors Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * Albumin greater than 2.5 g/dL * AST and ALT no greater than 3 times ULN * INR no greater than 1.5 (unless receiving anticoagulants) Renal * Creatinine no greater than 2 times ULN Cardiovascular * LVEF at least 50% * No New York Heart Association class III or IV cardiac disease * No acute anginal symptoms Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study * No severe concurrent disease, infection, or co-morbidity that would preclude study entry * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy for HCC * No concurrent therapeutic biological response modifier Chemotherapy * No prior chemotherapy for HCC * No prior chemoembolization for HCC * No other concurrent cytotoxic chemotherapy Endocrine therapy * At least 6 weeks since prior hormonal therapy (an indicator lesion must exist outside the area of therapy * No concurrent hormonal anticancer therapy Radiotherapy * No prior radiotherapy for HCC * At least 6 weeks since prior radiofrequency ablation, selective internal radiation, or embolization (an indicator lesion must exist outside the area of therapy) * No concurrent radiotherapy (including palliative therapy) Surgery * At least 6 weeks since prior surgical resection (an indicator lesion must exist outside the area of therapy) * Recurrence at the margin of the surgical resection is allowed * At least 6 weeks since prior cryosurgery * More than 4 weeks since other prior major surgery Other * More than 4 weeks since prior investigational therapy * At least 6 weeks since prior intratumoral ethanol injection (an indicator lesion must exist outside the area of therapy) * No other concurrent investigational anticancer therapy
References
Publications (0)
Data not yet available
No reference posted for this study.