Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors
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| ClinicalTrials.gov Identifier: NCT00470366 |
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Recruitment Status :
Completed
First Posted : May 7, 2007
Results First Posted : October 24, 2017
Last Update Posted : November 28, 2017
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RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy.
PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating patients with previously untreated germ cell tumors.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain and Central Nervous System Tumors Extragonadal Germ Cell Tumor Ovarian Cancer Teratoma Testicular Germ Cell Tumor | Biological: pegfilgrastim Drug: cisplatin Drug: ifosfamide Drug: paclitaxel | Phase 2 |
OBJECTIVES:
- Determine the efficacy of chemotherapy comprising paclitaxel, ifosfamide, and cisplatin in combination with pegfilgrastim in patients with previously untreated intermediate- or poor-risk germ cell tumors.
- Determine the safety of this regimen in these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 120-180 minutes on days 1 and 2, cisplatin IV over 30 minutes and ifosfamide IV over 120 minutes on days 1-5, and pegfilgrastim subcutaneously on day 6. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Some patients may required surgery after chemotherapy and, if viable non-teratomatous germ cell tumor is found in the surgical specimen and there is no interval disease progression, these patients may receive 1-2 more courses of chemotherapy after surgery.
After completion of study treatment, patients are followed up at 28 days and then every 2 months for up to 1 year.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Trial of Paclitaxel, Ifosfamide, and Cisplatin in Previously Untreated Intermediate and Poor Risk Germ Cell Tumor Patients |
| Study Start Date : | March 2007 |
| Actual Primary Completion Date : | June 2016 |
| Actual Study Completion Date : | June 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Paclitaxel, Ifosfamide, and Cisplatin
-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.
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Biological: pegfilgrastim Drug: cisplatin Drug: ifosfamide Drug: paclitaxel |
- Rate of Complete Response [ Time Frame: 3 years ]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
- Progression-free Survival [ Time Frame: Up to 8 years ]Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 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
- Percentage of Participants With Progression Free Survival [ Time Frame: 3 years ]Progression Free Survival at 3 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 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
- Number of Patients With Treatment Related Toxicity [ Time Frame: 3 years ]Toxicity evaluated and graded according to the National Cancer Institute, Version 3.0
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| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed germ cell tumor meeting 1 of the following criteria:
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Poor risk, defined by any of the following:
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Testis or retroperitoneal primary site nonseminoma histology without visceral metastases but with "poor-risk" markers, defined by any of the following:
- Pretreatment serum lactate dehydrogenase (LDH) > 10 times upper limit of normal (ULN)
- Pretreatment serum human chorionic gonadotropin (HCG) > 50,000 IU/L
- Pretreatment serum alpha fetoprotein (AFP) > 10,000 ng/mL
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Testis or retroperitoneal primary site nonseminoma histology with one or more nonpulmonary visceral metastases, including any of the following (regardless of serum tumor marker values):
- Bone metastases
- Brain metastases
- Hepatic metastases
- Any nonpulmonary metastases (i.e., skin, spleen)
- Mediastinal primary site nonseminoma histology regardless of serum tumor marker levels or presence/absence of visceral metastases
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Modified intermediate risk, defined by any of the following:
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Testis or retroperitoneal primary site nonseminoma histology with no nonpulmonary visceral metastases, and with any of the following serum marker values:
- Pretreatment serum LDH 3.0-10 times ULN
- Pretreatment serum HCG 5,000-50,000 IU/L
- Pretreatment serum AFP 1,000-10,000 ng/mL
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Seminoma histology with one or more nonpulmonary visceral metastases, including any of the following (regardless of serum tumor marker values or primary site):
- Bone metastases
- Brain metastases
- Hepatic metastases
- Any nonpulmonary visceral metastases (i.e., skin, spleen)
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- Previously untreated disease
- Measurable or evaluable disease
PATIENT CHARACTERISTICS:
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine normal or creatinine clearance > 50 mL/min (unless renal dysfunction is due to tumor obstructing the ureters)
- AST and ALT ≤ 3 times ULN
- Bilirubin ≤ 2.0 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent malignancy except for nonmelanoma skin cancer
- No known HIV positivity
- No active infections
PRIOR CONCURRENT THERAPY:
- Recovered from prior surgery
- More than 30 days since prior radiotherapy and recovered (unless evidence of progressive disease has been documented)
- No prior chemotherapy
- No other concurrent cytotoxic therapy
- Concurrent radiotherapy and surgery allowed for treatment of brain metastases
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470366
| United States, California | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90089-9181 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| Principal Investigator: | Darren Feldman, MD | Memorial Sloan Kettering Cancer Center | |
| Principal Investigator: | Robert J. Motzer, MD | Memorial Sloan Kettering Cancer Center |
Additional Information:
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00470366 History of Changes |
| Other Study ID Numbers: |
07-044 MSKCC-07044 |
| First Posted: | May 7, 2007 Key Record Dates |
| Results First Posted: | October 24, 2017 |
| Last Update Posted: | November 28, 2017 |
| Last Verified: | June 2016 |
Keywords provided by Memorial Sloan Kettering Cancer Center:
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stage II malignant testicular germ cell tumor stage III malignant testicular germ cell tumor testicular choriocarcinoma and embryonal carcinoma testicular choriocarcinoma and seminoma testicular choriocarcinoma and teratoma testicular choriocarcinoma and yolk sac tumor testicular choriocarcinoma testicular embryonal carcinoma and seminoma testicular embryonal carcinoma and teratoma with seminoma testicular embryonal carcinoma and teratoma testicular embryonal carcinoma and yolk sac tumor with seminoma testicular embryonal carcinoma and yolk sac tumor testicular embryonal carcinoma testicular seminoma testicular yolk sac tumor and teratoma with seminoma |
testicular yolk sac tumor and teratoma testicular yolk sac tumor stage I malignant testicular germ cell tumor adult central nervous system germ cell tumor ovarian choriocarcinoma ovarian dysgerminoma ovarian embryonal carcinoma ovarian yolk sac tumor ovarian immature teratoma ovarian mature teratoma ovarian monodermal and highly specialized teratoma ovarian polyembryoma ovarian mixed germ cell tumor stage IV ovarian germ cell tumor stage IV extragonadal seminoma |
Additional relevant MeSH terms:
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Neoplasms Neoplasms, Germ Cell and Embryonal Nervous System Neoplasms Central Nervous System Neoplasms Teratoma Testicular Neoplasms Neoplasms by Histologic Type Neoplasms by Site Nervous System Diseases Endocrine Gland Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Endocrine System Diseases Testicular Diseases |
Gonadal Disorders Paclitaxel Isophosphamide mustard Albumin-Bound Paclitaxel Cisplatin Ifosfamide Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents |