Phase 2
Completed N=60
Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors
Source: ClinicalTrials.gov NCT00470366 ↗Enrolled (actual)
60
Serious AEs
56.7%
Results posted
Oct 2017
Primary outcomePrimary: Rate of Complete Response — 38; 7; 11 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Complete Response |
38; 7; 11 | — |
| SECONDARY Progression-free Survival |
4.4 | — |
| SECONDARY Percentage of Participants With Progression Free Survival |
72 | — |
| SECONDARY Number of Patients With Treatment Related Toxicity |
60 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed germ cell tumor meeting 1 of the following criteria:
- Poor risk, defined by any of the following:
- 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
- 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
- Modified intermediate risk, defined by any of the following:
- 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
- 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)
- 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
Data sourced from ClinicalTrials.gov (NCT00470366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.