Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma

NCT02272816 | Completed Phase 2 Results

• 2 other identifiers: 0070652009-009882-33
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluated the safety, efficacy and toxicity of carboplatin area under the curve (AUC)-10 in metastatic seminoma to see if, by using fluoro-deoxyglucose (FDG) positron emission tomography-computed tomography (PET-CT) to assess metabolic response, the number of patients requiring 4 cycles can be reduced. Carboplatin AUC-10 was given every 21 days. A PET-CT scan was carried out on day 17-21 of the first cycle. If the PET - CT scan showed a complete response patients received 3 cycles of treatment. If the PET - CT scan did not show a complete response patients received 4 cycles of treatment. After treatment, patients were followed up for 2 years.

Conditions

Metastatic Seminoma

Outcome Measures

Primary Outcomes (1)

• 2 - Year Progression Free Survival

  Number of participants progression free 2 years after registration.

  2 years

Secondary Outcomes (2)

• Metabolic Response Rate

  21 days

• Overall Survival

  2 years

Study Arms (1)

Carboplatin AUC-10

EXPERIMENTAL

Drug: Carboplatin AUC-10

Interventions

Carboplatin AUC-10 DRUG

Carboplatin AUC-10 according to the Calvert formula \[10 x (glomerular filtration rate (ml/min) + 25)\]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.

Carboplatin AUC-10

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic seminoma with International Germ Cell Consensus Classification (IGCCCG) good prognosis.
• Glomerular filtration rate (GFR) by Ethylenediaminetetraacetic acid (EDTA) clearance over 25 ml/min.
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-3.
• Normal Alpha-fetoprotein (All levels of Human chorionic gonadotropin and Lactate dehydrogenase are acceptable).
• Males aged ≥18 and ≤75 years.
• Able to give written informed consent prior to study entry.
• Patients must be sterile or agree to use adequate contraception during the period of therapy.

You may not qualify if:

• Metastatic seminoma with any non-pulmonary visceral metastases.
• Raised Alpha-fetoprotein.
• Any previous chemotherapy or radiotherapy.
• Currently enrolled in any other investigational drug study.
• Other malignancy except basal cell.

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• University College London Hospitals: collaborator

Study Sites (2)

Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

Location

Hillingdon Hospitals NHS Foundation Trust

London, HA6 2RN, United Kingdom

Location

Related Publications (10)

• Horwich A, Oliver RT, Wilkinson PM, Mead GM, Harland SJ, Cullen MH, Roberts JT, Fossa SD, Dearnaley DP, Lallemand E, Stenning SP; MRC Testicular Tumour Working Party. A medical research council randomized trial of single agent carboplatin versus etoposide and cisplatin for advanced metastatic seminoma. MRC Testicular Tumour Working Party. Br J Cancer. 2000 Dec;83(12):1623-9. doi: 10.1054/bjoc.2000.1498.

  PMID: 11104556 BACKGROUND

• Bokemeyer C, Kollmannsberger C, Stenning S, Hartmann JT, Horwich A, Clemm C, Gerl A, Meisner C, Ruckerl CP, Schmoll HJ, Kanz L, Oliver T. Metastatic seminoma treated with either single agent carboplatin or cisplatin-based combination chemotherapy: a pooled analysis of two randomised trials. Br J Cancer. 2004 Aug 16;91(4):683-7. doi: 10.1038/sj.bjc.6602020.

  PMID: 15266338 BACKGROUND

• Shamash J, McLaren B, LeVay JH, Ong J, Murray P, Asterling S, Oliver RT. Carboplatin AUC8 in combination with etoposide and bleomycin in the treatment of intermediate and poor-risk metastatic germ cell tumours: a phase II study. Cancer Chemother Pharmacol. 2001 Apr;47(4):370-2. doi: 10.1007/s002800000217.

  PMID: 11345655 BACKGROUND

• Horwich A, Sleijfer DT, Fossa SD, Kaye SB, Oliver RT, Cullen MH, Mead GM, de Wit R, de Mulder PH, Dearnaley DP, Cook PA, Sylvester RJ, Stenning SP. Randomized trial of bleomycin, etoposide, and cisplatin compared with bleomycin, etoposide, and carboplatin in good-prognosis metastatic nonseminomatous germ cell cancer: a Multiinstitutional Medical Research Council/European Organization for Research and Treatment of Cancer Trial. J Clin Oncol. 1997 May;15(5):1844-52. doi: 10.1200/JCO.1997.15.5.1844.

  PMID: 9164194 BACKGROUND

• Gore M, Mainwaring P, A'Hern R, MacFarlane V, Slevin M, Harper P, Osborne R, Mansi J, Blake P, Wiltshaw E, Shepherd J. Randomized trial of dose-intensity with single-agent carboplatin in patients with epithelial ovarian cancer. London Gynaecological Oncology Group. J Clin Oncol. 1998 Jul;16(7):2426-34. doi: 10.1200/JCO.1998.16.7.2426.

  PMID: 9667260 BACKGROUND

• Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.

  PMID: 17242396 BACKGROUND

• Juweid ME, Stroobants S, Hoekstra OS, Mottaghy FM, Dietlein M, Guermazi A, Wiseman GA, Kostakoglu L, Scheidhauer K, Buck A, Naumann R, Spaepen K, Hicks RJ, Weber WA, Reske SN, Schwaiger M, Schwartz LH, Zijlstra JM, Siegel BA, Cheson BD; Imaging Subcommittee of International Harmonization Project in Lymphoma. Use of positron emission tomography for response assessment of lymphoma: consensus of the Imaging Subcommittee of International Harmonization Project in Lymphoma. J Clin Oncol. 2007 Feb 10;25(5):571-8. doi: 10.1200/JCO.2006.08.2305. Epub 2007 Jan 22.

  PMID: 17242397 BACKGROUND

• A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001 Mar 30;20(6):859-66. doi: 10.1002/sim.721.

  PMID: 11252008 BACKGROUND

• Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

  PMID: 7165009 BACKGROUND

• Shamash J, Syed R, Sarker SJ, Sarwar N, Sharma A, Mutsvangwa K, Coetzee C, Wilson P, Rustin GJ. A phase II study of carboplatin AUC-10 guided by positron emission tomography-defined metabolic response in metastatic seminoma. Eur J Cancer. 2019 Jul;115:128-135. doi: 10.1016/j.ejca.2019.04.013. Epub 2019 May 25.

  PMID: 31136925 DERIVED

MeSH Terms

Conditions

Seminoma

Condition Hierarchy (Ancestors)

Germinoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Project Lead
• Organization: Centre for Experimental Cancer Medicine, Barts Cancer Institute, QMUL

bci-carpet@qmul.ac.uk

02078828277

Study Officials

• Jonathan Shamash, MD FRCP

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: October 23, 2014
• Study Start: February 13, 2012
• Primary Completion: October 13, 2017
• Study Completion: October 13, 2017
• Last Updated: January 25, 2019
• Results First Posted: January 25, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)