CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Alvocidib Hydrochloride +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00957905
NCT00957905Phase 2Completed
CompareCT.gov

A Non-randomized Phase 2 Study of Alvocidib (Flavopiridol) Plus Oxaliplatin With or Without 5-FU and Leucovorin for Relapsed or Refractory Germ-Cell Tumors

National Cancer Institute (NCI)·interventional·Posted Aug 13, 2009·Updated Mar 10, 2017

In Brief

A Phase 2 clinical trial evaluating Alvocidib Hydrochloride, Fluorouracil, and 2 other interventions for Recurrent Extragonadal Seminoma and 8 related conditions. Completed, enrolled 36 participants across 10 sites.

Detailed Summary

This phase II trial is studying alvocidib and oxaliplatin to see how well they work when given with or without fluorouracil and leucovorin calcium in treating patients with relapsed or refractory germ cell tumors. Drugs used in chemotherapy, such as alvocidib, oxaliplatin, fluorouracil, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving alvocidib together with oxaliplatin with or without fluorouracil and leucovorin calcium may kill more tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Extragonadal Seminoma, Recurrent Malignant Extragonadal Germ Cell Tumor, Recurrent Malignant Extragonadal Non-Seminomatous Germ Cell Tumor, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Ovarian Germ Cell Tumor, Stage III Testicular Cancer, Stage IV Extragonadal Non-Seminomatous Germ Cell Tumor, Stage IV Extragonadal Seminoma, Stage IV Ovarian Germ Cell Tumor
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 13, 2009
Enrollment StartJun 1, 2009
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 16.9 years ago

Interventions

Alvocidib Hydrochloridedrug

Given IV

Fluorouracildrug

Given IV

Leucovorin Calciumdrug

Given IV

Oxaliplatindrug

Given IV