Gemcitabine, Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Progressive or Relap… (NCT00551122) | Clinical Trial Compass
UnknownPhase 1/2
Gemcitabine, Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Progressive or Relapsed Metastatic Germ Cell Tumors
United Kingdom23 participantsStarted 2006-11
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, ifosfamide, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with paclitaxel, ifosfamide, and cisplatin, and to see how well they work in treating patients with progressive or relapsed metastatic germ cell tumors.
Who can participate
Age range
16 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Meets the following criteria:
* Histologically confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma
* Unresectable metastatic disease
* No completely resected cancer
* Rising serum markers (i.e., alpha-fetoprotein and human chorionic gonadotropin) on sequential measurement or biopsy-proven unresectable germ cell cancer
* In first relapse after a single prior cisplatin-containing combination chemotherapy
* Patients with late relapse (i.e., \> 2 years post initial chemotherapy) should be considered for surgery rather than chemotherapy, if technically feasible
* No patients with cerebral metastases alone
* Progressive cerebral and systemic disease may be considered for this study, provided cranial irradiation is also considered as a component of care
PATIENT CHARACTERISTICS:
* Medically and psychologically fit to receive this intensive chemotherapy schedule
* WBC \> 3.5 times 10\^9/L
* Platelet count \> 130 times 10\^9/L
* Glomerular filtration rate ≥ 50 mL/min (as determined by 24 hour creatinine clearance or nuclear medicine technique)
* Fertile patients must use effective contraception
* No other prior malignancy except successfully treated nonmelanoma skin cancer or superficial bladder cancer
* No prior allergic reactions to cisplatin or other platinum compounds
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose of gemcitabine hydrochloride when administered with TIP chemotherapy comprising paclitaxel, ifosfamide, and cisplatin with growth factor support (phase I)
Timeframe: end of study
2
Response rates (phase I)
Timeframe: end of study
3
Failure-free survival (phase I)
Timeframe: end of study
4
Utility of positron emission tomography scanning after Gem-TIP chemotherapy (phase I)
Timeframe: end of study
5
Degree of dose intensification achieved with Gem-TIP chemotherapy relative to a previous Medical Research Council study with TIP alone (phase II)