Ovarian CancerPhase 1/2NCT00002559
Combination Chemotherapy in Treating Patients With Germ Cell Tumors That Have Not Responded to Previous Cisplatin
A Phase 1/2 study testing filgrastim, cisplatin and ifosfamide in people with Ovarian Cancer and Testicular Germ Cell Tumor, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel, cisplatin, and ifosfamide in… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Ovarian Cancer, Testicular Germ Cell Tumor
- What is being tested?
- filgrastim, cisplatin and ifosfamide
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1994to Jan 2003
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven germ cell tumor that is resistant to a platinum-based chemotherapy regimen
- Active disease meeting 1 of the following conditions:
- Measurable or evaluable disease
- Elevated serum tumor markers (alpha-fetoprotein or human chorionic gonadotropin)
- Unresectable residual disease after postchemotherapy surgery
- Favorable prognostic factors for achieving a complete response (CR) to cisplatin-based salvage therapy required, including all of the following:
- No more than 1 prior regimen or 6 prior courses of cisplatin
- Testis or ovarian germ cell primary site
- Prior CR to cisplatin therapy
- Incomplete response to first-line therapy that was based on either carboplatin or a suboptimal regimen of cisplatin
PATIENT CHARACTERISTICS:
Age:
- 15 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8.0 g/dL
Hepatic:
- Not specified
Renal:
- Creatinine clearance greater than 50 mL/min
- Renal dysfunction due to ureteral obstruction by tumor allowed at the discretion of the principal investigator
Cardiovascular:
- If history of significant cardiac disease, evaluation and clearance by a cardiologist required prior to entry
Other:
- No active infection not well controlled on antibiotics
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No prior paclitaxel or ifosfamide
- At least 3 weeks since prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
- Recovered from recent surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: PHASE I/II TRIAL OF TAXOL, IFOSFAMIDE, AND CISPLATIN FOR CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS WITH FAVORABLE PROGNOSTIC FEATURES
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel, cisplatin, and ifosfamide in treating patients who have ovarian or testicular germ cell tumors that are refractory to platinum-containing chemotherapy.
Read the detailed description
OBJECTIVES:
- Determine the toxicity and optimal dose of paclitaxel when combined with cisplatin and ifosfamide in patients with germ cell tumors with favorable prognostic features and resistance to cisplatin.
- Determine the efficacy of this regimen as salvage therapy in these patients.
OUTLINE: This is a dose escalation study of paclitaxel.
Patients receive paclitaxel IV continuously on day 1 and cisplatin IV over 20 minutes and ifosfamide IV over 30 minutes on days 2-6. Filgrastim (G-CSF) is administered subcutaneously (SC) on days 7-18 or until blood counts recover. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. Additional patients receive paclitaxel at the MTD.
After completion of chemotherapy, some patients may undergo resection of residual masses.
PROJECTED ACCRUAL: A total of 18-43 patients will be accrued for this study within 2 years.
- Conditions
- Ovarian Cancer, Testicular Germ Cell Tumor
- Being tested
- filgrastim, cisplatin, ifosfamide, paclitaxel
- Keywords
- recurrent malignant testicular germ cell tumor, recurrent ovarian germ cell tumor
- Medical subject headings
- Ovarian Neoplasms, Testicular Germ Cell Tumor, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
cisplatinDrug
ifosfamideDrug
paclitaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2003 (estimated)
- Study startJan 1994
- Primary completionJan 2003
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 1/2
- Primary purpose
- Treatment
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Robert J. Motzer, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002559
- Sponsor's protocol ID
- 94-012
- Other IDs
- CDR0000063452, NCI-V94-0408
- Status last verified
- Jul 2013
- First submitted
- 1 Nov 1999
- Last updated
- 2 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE I/II TRIAL OF TAXOL, IFOSFAMIDE, AND CISPLATIN FOR CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS WITH FAVORABLE PROGNOSTIC FEATURES
- ClinicalTrials.gov ID
- NCT00002559
- Acronym / sponsor ID
- 94-012
- Conditions
- Ovarian Cancer, Testicular Germ Cell Tumor
- Keywords
- recurrent malignant testicular germ cell tumor, recurrent ovarian germ cell tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jan 1994
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 18 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel, cisplatin, and ifosfamide in treating patients who have ovarian or testicular germ cell tumors that are refractory to platinum-containing chemotherapy.
Detailed description
OBJECTIVES:
- Determine the toxicity and optimal dose of paclitaxel when combined with cisplatin and ifosfamide in patients with germ cell tumors with favorable prognostic features and resistance to cisplatin.
- Determine the efficacy of this regimen as salvage therapy in these patients.
OUTLINE: This is a dose escalation study of paclitaxel.
Patients receive paclitaxel IV continuously on day 1 and cisplatin IV over 20 minutes and ifosfamide IV over 30 minutes on days 2-6. Filgrastim (G-CSF) is administered subcutaneously (SC) on days 7-18 or until blood counts recover. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. Additional patients receive paclitaxel at the MTD.
After completion of chemotherapy, some patients may undergo resection of residual masses.
PROJECTED ACCRUAL: A total of 18-43 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| filgrastim | Biological | – |
| cisplatin | Drug | – |
| ifosfamide | Drug | – |
| paclitaxel | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
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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.
Robert J. Motzer, MD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing filgrastim, cisplatin and ifosfamide in people with Ovarian Cancer and Testicular Germ Cell Tumor, run by Memorial Sloan Kettering Cancer Center at 1 site 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?
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 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 2 Jul 2013.