Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors

NCT00453232 | Completed Phase 2

• 5 other identifiers: CRCA-CCTC-ACCELERATED-BEPCDR0000537042EUDRACT-2004-000847-79EU-20713ISRCTN18505589
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 7

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating men with metastatic germ cell tumors.

Conditions

Extragonadal Germ Cell Tumor; Teratoma; Testicular Germ Cell Tumor

Keywords

stage III malignant testicular germ cell tumor; testicular choriocarcinoma and seminoma; testicular embryonal carcinoma and seminoma; testicular choriocarcinoma and embryonal carcinoma; testicular choriocarcinoma and teratoma; testicular choriocarcinoma; testicular choriocarcinoma and yolk sac tumor; 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; testicular yolk sac tumor and teratoma with seminoma; testicular yolk sac tumor and teratoma; recurrent malignant testicular germ cell tumor; recurrent extragonadal non-seminomatous germ cell tumor; recurrent extragonadal seminoma; stage IV extragonadal non-seminomatous germ cell tumor; stage IV extragonadal seminoma; adult teratoma; testicular immature teratoma; testicular mature teratoma; recurrent extragonadal germ cell tumor

Outcome Measures

Primary Outcomes (2)

• Toxicity

• Feasibility

Secondary Outcomes (2)

• Response rate

• Progression-free survival

Interventions

bleomycin sulfate BIOLOGICAL

pegfilgrastim BIOLOGICAL

cisplatin DRUG

etoposide DRUG

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Patients must fulfill all of the following criteria for 1 of the following diagnoses: * Nonseminoma germ cell tumor (intermediate risk) * Testis or retroperitoneal primary * Abnormal markers (alpha fetoprotein \[AFP\] \> 1,000 and \< 10,000 ng/mL, human chorionic gonadotropin \[HCG\] \> 5,000 and \< 50,000 IU/L, lactate dehydrogenase \[LDH\] \> 1.5 times and \< 10 times upper limit of normal \[ULN\]) * No liver, bone, brain, or other nonpulmonary visceral metastasis * Histologic confirmation is not required if AFP or HCG are grossly elevated * Nonseminoma germ cell tumor (poor prognosis) meeting 1 of the following criteria: * Mediastinal primary * Nonpulmonary visceral metastases * Poor markers (AFP \> 10,000 ng/mL, HCG \> 50,000 IU/L, LDH \> 10 times ULN) * Histologic confirmation not required if AFP or HCG are grossly elevated * Seminoma (intermediate prognosis) * Histological confirmation is required * Any primary site * Nonpulmonary visceral metastases must be present * Normal AFP * Any HCG * Any LDH * Surveillance relapse * Must fulfill appropriate criteria above according to initial histology PATIENT CHARACTERISTICS: * Neutrophil count ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ * Must have adequate renal function (creatinine clearance ≥ 60 mL/min) * No prior malignancy except basal cell carcinoma PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (7)

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Churchill Hospital

Oxford, England, OX3 7LJ, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

MeSH Terms

Conditions

Teratoma; Testicular Germ Cell Tumor; Testicular Neoplasms; Seminoma; Carcinoma, Embryonal; Endodermal Sinus Tumor

Interventions

Bleomycin; pegfilgrastim; Cisplatin; Etoposide

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Germinoma; Mesonephroma

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides

Study Officials

• Michael Williams, MD

  Cambridge University Hospitals NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 28, 2007
• Study Start: August 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: August 7, 2013

Record last verified: 2007-08

Locations

GB (7)