Clinical trial · Interventional
Alvocidib in Treating Patients With Locally Advanced or Metastatic Solid Tumors
A Pilot Study of Flavopiridol in Patients With Advanced Solid Tumors
NCT00112684CI-TRIAL-00013849terminatedPhase 1ClinicalTrials.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)
This phase I trial is studying the side effects and best dose of alvocidib in treating patients with locally advanced or metastatic solid tumors. Drugs used in chemotherapy, such as alvocidib, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Alvocidib may also stimulate the immune system in different ways and stop tumor cells from growing. It may also stop the growth of solid tumors by blocking blood flow to the tumor.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alvocidib | Drug | Alvocidib | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy, biological therapy)
- description
- Patients receive alvocidib IV over 4½ hours once weekly in weeks 1-4. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: alvocidib
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Adverse events of dose escalated alvocidib administered in patients with advanced solid tumors
- timeFrame
- At weeks 1-4, 7-10, 11 or 12, and within 4 weeks after the completion of study treatment
- description
- Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically or cytologically confirmed solid tumor
* Locally advanced or metastatic disease for which curative treatment does not exist or is no longer effective
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* No previously irradiated\* measurable lesion unless lesion demonstrates progressive disease OR there are other measurable lesions outside the irradiated\* field
* The following are not considered measurable disease:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural or pericardial effusion
* Lymphangitis cutis/pulmonis
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* No uncontrolled brain metastases
* Performance status - ECOG 0-1
* At least 6 months
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* Creatinine ≤ 1.5 times ULN
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No uncontrolled cardiac arrhythmia
* No uncontrolled hypertension
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of allergic reaction attributed to compounds of similar chemical or biological composition to flavopiridol
* No ongoing or active infection
* No uncontrolled illness
* No psychiatric illness or social situation that would preclude study compliance
* More than 12 weeks since prior hepatic arterial chemoembolization
* More than 4 weeks since prior systemic chemotherapy
* No prior flavopiridol
* See Disease Characteristics
* More than 12 weeks since prior radioactive metaiodobenzylguanidine (MIBG)
* More than 4 weeks since prior external beam radiotherapy
* Recovered from all prior tumor-specific therapy
* More than 4 weeks since prior investigational tumor-specific therapy
* Concurrent octreotide for control of carcinoid syndrome allowed
* No concurrent combination anti-retroviral therapy for HIV-positive patients
* No other concurrent tumor-specific therapy
* No other concurrent investigational therapy
* No other concurrent anticancer therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.