Neoplasms, Germ Cell and EmbryonalPhase 2NCT00393861
Study of Oxaliplatin Plus Bevacizumab in Germ Cell Tumor Patients
A Phase 2 study testing Bevacizumab and Oxaliplatin in people with Neoplasms, Germ Cell and Embryonal, run by Indiana University at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of oxaliplatin and bevacizumab in patients with refractory or relapsed germ cell tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Germ Cell and Embryonal
- What is being tested?
- Bevacizumab and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2006to Nov 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histological or serologic proof of metastatic germ cell neoplasm (gonadal or extragonadal primary). Patients with seminoma and non-seminoma are eligible, as are women with ovarian germ cell tumors.
- Patient's disease must not be amenable to cure with either surgery or chemotherapy in the opinion of the investigator.
- Patients must have failed initial cisplatin combination chemotherapy administered with curative intent such as BEP, EP, VIP, or similar regimens.
- Patients should have failed and demonstrated progressive disease with high dose chemotherapy such as carboplatin and etoposide. (With the exception of late relapse or primary mediastinal non-seminomatous germ cell tumor.
- Patients with late relapse or primary mediastinal non-seminomatous germ cell tumors must have failed at least 1 salvage chemotherapy regimen.
- Patients must have had prior exposure to paclitaxel, gemcitabine, or the combination of paclitaxel + gemcitabine.
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- Patients must have adequate hematologic function (WBC > 4,000/mm3 and platelets > 100,000/mm3) obtained < 4 weeks prior to registration.
- Patients must have adequate hepatocellular function (SGOT < 4 x normal and Bilirubin <2.0 mg/dl) obtained < 4 weeks from protocol registration.
- Serum Creatinine must be < 2.0 mg/dl obtained < 4 weeks from protocol registration.
- Patients must have an ECOG performance status of 0, 1, or 2.
- Patients must be at least 28 days post major surgery, open biopsy, or significant traumatic injury at time of study registration.
- Patients must be at least 7 days post any minor surgical procedure, excluding placement of a vascular access device at the time of study registration.
- Patients must be at least 18 years old at time of consent.
Who cannot join
- Patients who have an active, unresolved infection and/or are receiving concurrent treatment with parenteral antibiotics are ineligible. Patients are eligible after antibiotics have been discontinued for at least 7 days.
- Patients may not have any significant bleeding.
- Patients with INR > 1.5 are not eligible unless the patient is on anti-coagulants with a therapeutic INR between 1.5 and 3. Patients on coumadin are not eligible unless they are on low dose coumadin to keep a vascular access device patent.
- Patients with a history of arterial thromboses, unstable angina, transient ischemic attach (TIA), cerebral vascular accident (CVA), or a myocardial infarction within the last 6 months are not eligible.
- Patients must not have known CNS metastases. A Head CT or MRI will be performed only if clinically indicated.
- Patients must not have received any radiotherapy or chemotherapy within 28 days prior to study registration, and have recovered from all toxicity from prior treatments.
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- Patients must not have any prior history of hypertensive crisis or hypertensive encephalopathy.
- Patients must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- Patients must not have history of significant vascular disease.
- Patients must not have evidence of bleeding diathesis or coagulopathy.
- Patients must not have inadequately controlled hypertension (defined as systolic blood pressure 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications).
- Patients must not have history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study registration.
- Patients must not have serious, non-healing would, ulcer or bone fracture.
- Patients must not have proteinuria at screening as demonstrated by a urine protein: Creatinine (UPC) ratio of ≥ 1.0.
- Patients must not have a known sensitivity to any component of bevacizumab.
- Patients must not be pregnant or lactating.
- Patients must not have grade 3 or 4 neuropathy.
- Females of child bearing potential must not be pregnant. A negative pregnancy test is required within 7 days prior to beginning treatment.
- NOTE THE FOLLOWING GUIDELINES FOR USE IN THIS PROTOCOL:
- Progressive metastatic disease will be documented by the appearance of metastatic lesions on PA and lateral chest x-ray, C.T. scan, or other imaging studies, or the presence of a rising serum HCG or AFP.
- If a rising serum marker is the only evidence of progressive disease, at least 2 consecutive determinations must be done exhibiting serologic progression and alternative causes for increased serum levels of these substances must not be present [cross reaction with LH (tested if necessary by testosterone suppression of LH), ingestion of marijuana, hepatitis, etc.].
- Patients will be considered to have failed a prior regimen if they fail to obtain a complete response per RECIST as outlined in section 6.
- Patients with clinical situation of growing teratoma (normal or declining markers and radiographic or clinical progression) should be considered for surgery.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana Univeristy Cancer Center
Indianapolis, Indiana, 46202
University of Pennsylvania:Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Phase II Study of Oxaliplatin Plus Bevacizumab Salvage Chemotherapy in Patients With Germ Cell Tumors
The purpose of this study is to evaluate the effectiveness of oxaliplatin and bevacizumab in patients with refractory or relapsed germ cell tumors.
Read the detailed description
This study proposes to look at the established combination of oxaliplatin and bevacizumab as used in colorectal cancer in refractory germ cell tumor patients. Oxaliplatin is a drug of known activity. Although bevacizumab has no single agent data, it combines dramatically well with numerous chemotherapy drugs, such as oxaliplatin increasing response rates and improving survival. Furthermore, VEG-F appears to be an important target in germ cell tumors as it does in so many other types of solid tumors. We will be using the identical dosages of oxaliplatin + bevacizumab as has been utilized in previously treated colorectal cancer, without the addition of 5-FU + leucovorin. This dose and schedule has been proven to be safe and effective.
- Conditions
- Neoplasms, Germ Cell and Embryonal
- Being tested
- Bevacizumab and Oxaliplatin
- Keywords
- Germ Cell Tumor, Germ Cell Cancer
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab and OxaliplatinDrug
Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
| Study group | Role | What they receive |
|---|---|---|
| oxaliplatin & bevacizumab | Experimental | Not described Receives: Drug: Bevacizumab and Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Twelve Month Disease-free Survival Rate
The percent of patients being disease-free at 12 months after treatment initiation will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug.
Measured: 12 month post completion of treatment
Secondary outcomes (3)
Objective Response Rate (Complete and Partial Response)
The percent of patients having an objective response (complete or partial response) will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: completion of study, up to 5 years
Duration of Remission (CR + PR)
Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis.
Measured: completion of study, up to 5 years
Overall Survival
Will be examined using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis.
Measured: completion of study, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2012
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neoplasms, Germ Cell and EmbryonalStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Lawrence Einhorn, MD, Principal investigator, Indiana Univeristy School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393861
- Sponsor's protocol ID
- 0609-11; IUCRO-0166
- Other IDs
- IUCRO-0166, AVF4003s
- Status last verified
- Feb 2016
- First submitted
- 26 Oct 2006
- Last updated
- 24 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Oxaliplatin Plus Bevacizumab Salvage Chemotherapy in Patients With Germ Cell Tumors
- ClinicalTrials.gov ID
- NCT00393861
- Acronym / sponsor ID
- 0609-11; IUCRO-0166
- Conditions
- Neoplasms, Germ Cell and Embryonal
- Keywords
- Germ Cell Tumor, Germ Cell Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Oct 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Oct 2006 (estimated)
- Results
- Posted 29 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of oxaliplatin and bevacizumab in patients with refractory or relapsed germ cell tumors.
Detailed description
This study proposes to look at the established combination of oxaliplatin and bevacizumab as used in colorectal cancer in refractory germ cell tumor patients. Oxaliplatin is a drug of known activity. Although bevacizumab has no single agent data, it combines dramatically well with numerous chemotherapy drugs, such as oxaliplatin increasing response rates and improving survival. Furthermore, VEG-F appears to be an important target in germ cell tumors as it does in so many other types of solid tumors. We will be using the identical dosages of oxaliplatin + bevacizumab as has been utilized in previously treated colorectal cancer, without the addition of 5-FU + leucovorin. This dose and schedule has been proven to be safe and effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oxaliplatin & bevacizumab | Experimental | Drug: Bevacizumab and Oxaliplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must have histological or serologic proof of metastatic germ cell neoplasm (gonadal or extragonadal primary). Patients with seminoma and non-seminoma are eligible, as are women with ovarian germ cell tumors.
- Patient's disease must not be amenable to cure with either surgery or chemotherapy in the opinion of the investigator.
- Patients must have failed initial cisplatin combination chemotherapy administered with curative intent such as BEP, EP, VIP, or similar regimens.
- Patients should have failed and demonstrated progressive disease with high dose chemotherapy such as carboplatin and etoposide. (With the exception of late relapse or primary mediastinal non-seminomatous germ cell tumor.
- Patients with late relapse or primary mediastinal non-seminomatous germ cell tumors must have failed at least 1 salvage chemotherapy regimen.
Key exclusion criteria (23 listed)
- Patients who have an active, unresolved infection and/or are receiving concurrent treatment with parenteral antibiotics are ineligible. Patients are eligible after antibiotics have been discontinued for at least 7 days.
- Patients may not have any significant bleeding.
- Patients with INR > 1.5 are not eligible unless the patient is on anti-coagulants with a therapeutic INR between 1.5 and 3. Patients on coumadin are not eligible unless they are on low dose coumadin to keep a vascular access device patent.
- Patients with a history of arterial thromboses, unstable angina, transient ischemic attach (TIA), cerebral vascular accident (CVA), or a myocardial infarction within the last 6 months are not eligible.
- Patients must not have known CNS metastases. A Head CT or MRI will be performed only if clinically indicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab and OxaliplatinOxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes | Drug | oxaliplatin & bevacizumab |
Primary outcome
Twelve Month Disease-free Survival Rate
Time frame: 12 month post completion of treatment
The percent of patients being disease-free at 12 months after treatment initiation will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug.
3 secondary outcomes
Objective Response Rate (Complete and Partial Response)
Time frame: completion of study, up to 5 years
Duration of Remission (CR + PR)
Time frame: completion of study, up to 5 years
Overall Survival
Time frame: completion of study, up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Einhorn, MD principal investigator
Indiana Univeristy School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab and Oxaliplatin in people with Neoplasms, Germ Cell and Embryonal, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Twelve Month Disease-free Survival Rate (time frame: 12 month post completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.