Trial · NCT00957905
Alvocidib and Oxaliplatin With or Without Fluorouracil and Leucovorin Calcium in Treating Patients With Relapsed or Refractory Germ Cell Tumors
NCT00957905, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-03-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Alvocidib and Oxaliplatin With or Without Fluorouracil and Leucovorin Calcium in Treating Patients With Relapsed or Refractory Germ Cell Tumors. Trials, record NCT00957905. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00957905
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alvocidib and Oxaliplatin With or Without Fluorouracil and Leucovorin Calcium in Treating Patients With Relapsed or Refractory Germ Cell Tumors
- NCT number
- NCT00957905
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Recurrent 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
- Interventions
- Alvocidib Hydrochloride, Fluorouracil, Leucovorin Calcium, Oxaliplatin
- First posted
- 2009-08-13
- Last updated
- 2017-03-10
- Results first posted
- 2017-03-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | Within 3 courses of treatment | Number of Participants with Partial Response (PR), Stable Disease (SD), Progression of Disease (POD) Per Response Evaluation Criteria In Solid Tumors Criteria" (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Other | Toxicity | Up to 4 years | graded using the NCI CTCAE version 4.0.See adverse event section |
| Other | Progression-free Survival | From treatment start until first documented progression or death, assessed up to 4 years | |
| Other | Time to Tumor Response | From treatment start until first documented CR or PR, assessed up to 4 years |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate | Within 3 courses of treatment | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Toxicity | Up to 4 years | |||
| OTHER_PRE_SPECIFIED | Progression-free Survival | From treatment start until first documented progression or death, assessed up to 4 years | |||
| OTHER_PRE_SPECIFIED | Time to Tumor Response | From treatment start until first documented CR or PR, assessed up to 4 years |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate | Part A (Alvocidib and Oxaliplatin) | Partial Response | 0 | participants | |
| Objective Response Rate | Part B (Alvocidib and FOLFOX) | Partial Response | 6 | participants | |
| Objective Response Rate | Part A (Alvocidib and Oxaliplatin) | Stable Disease | 2 | participants | |
| Objective Response Rate | Part B (Alvocidib and FOLFOX) | Stable Disease | 10 | participants | |
| Objective Response Rate | Part A (Alvocidib and Oxaliplatin) | Progression of Disease | 5 | participants | |
| Objective Response Rate | Part B (Alvocidib and FOLFOX) | Progression of Disease | 9 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A | STARTED | Part A | 7 | |
| Part A | STARTED | Part B | 0 | |
| Part A | COMPLETED | Part A | 7 | |
| Part A | COMPLETED | Part B | 0 | |
| Part A | NOT COMPLETED | Part A | 0 | |
| Part A | NOT COMPLETED | Part B | 0 | |
| Part B | STARTED | Part A | 0 | |
| Part B | STARTED | Part B | 29 | |
| Part B | COMPLETED | Part A | 0 | |
| Part B | COMPLETED | Part B | 25 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events82
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alkaline phosphatase increased | Investigations | Part A (Alvocidib and Oxaliplatin) | 2 | 7 | 5 |
| other | Alkaline phosphatase increased | Investigations | Part B (Alvocidib and FOLFOX) | 2 | 29 | 7 |
| other | Anemia | Blood and lymphatic system disorders | Part A (Alvocidib and Oxaliplatin) | 2 | 7 | 18 |
| other | Anemia | Blood and lymphatic system disorders | Part B (Alvocidib and FOLFOX) | 8 | 29 | 46 |
| other | Blood bilirubin increased | Investigations | Part A (Alvocidib and Oxaliplatin) | 1 | 7 | 3 |
| other | Blood bilirubin increased | Investigations | Part B (Alvocidib and FOLFOX) | 0 | 29 | 0 |
| other | Creatinine increased | Investigations | Part A (Alvocidib and Oxaliplatin) | 1 | 7 | 3 |
| other | Creatinine increased | Investigations | Part B (Alvocidib and FOLFOX) | 1 | 29 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Part A (Alvocidib and Oxaliplatin) | 1 | 7 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Part B (Alvocidib and FOLFOX) | 4 | 29 | 10 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A (Alvocidib and Oxaliplatin) | ||
| Total, all-cause mortality | Part B (Alvocidib and FOLFOX) | ||
| Total, other adverse events | Part A (Alvocidib and Oxaliplatin) | 5 | 7 |
| Total, other adverse events | Part B (Alvocidib and FOLFOX) | 23 | 29 |
| Total, serious adverse events | Part A (Alvocidib and Oxaliplatin) | 4 | 7 |
| Total, serious adverse events | Part B (Alvocidib and FOLFOX) | 7 | 29 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants6
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA008748 | Cancer Center Support Grant | Rudin, Charles M. | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| U01CA062491 | Early Clinical Trials of New Anti-Cancer Agents with Phase 1 Emphasis (U01) | LIU, GLENN | UNIVERSITY OF WISCONSIN-MADISON | NATIONAL CANCER INSTITUTE | 1994 to 2013 | NIH RePORTER |
| U01CA062505 | Phase I Molecular and Clincal Pharmacodynamic Trials | NEWMAN, EDWARD M | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1994 to 2013 | NIH RePORTER |
| U01CA069856 | Early Clinical Trials of New Anti-Cancer Agents with Phase 1 Emphasis | SPRIGGS, DAVID R | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 1995 to 2013 | NIH RePORTER |
| U01CA069912 | Phase I Clinical Trials of Anticancer Agents | ERLICHMAN, CHARLES | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1995 to 2013 | NIH RePORTER |
| U01CA099168 | Early Clinical Trials of New Anti-Cancer Agents with Phase I Emphasis | CHU, EDWARD | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL CANCER INSTITUTE | 2003 to 2013 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Part A (Alvocidib and Oxaliplatin) vs Part B (Alvocidib and FOLFOX): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00957905
GET https://conductscience.org/api/trials/v1/NCT00957905/events?page=2