A Phase II Trial of Vinflunine Chemotherapy in Locally-advanced and Metastatic Carcinoma of the Penis (VinCaP)

NCT ID: NCT02057913

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-17
• Study Completion Date: 2018-11-06

Brief Summary

VinCaP is a multicentre single-arm phase II trial. 22 patients will receive Vinflunine chemotherapy (Vinflunine 320mg/m2 given intravenously on day 1 of each cycle of 21 days, four cycles to be given prior to formal re-staging).

Conditions

Locally-advanced or Metastatic Penile Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vinflunine

All patients will receive on Day 1 of a 21 day cycle, vinflunine 320mg/m2 via intravenous infusion in either 100ml sodium chloride 0.9% or glucose 5% over 20 minutes; four cycles to be given in total prior to formal re-staging.

Group Type: EXPERIMENTAL

Vinflunine

Intervention Type: DRUG

All patients will receive on Day 1 of a 21 day cycle, vinflunine 320mg/m2 via intravenous infusion in either 100ml sodium chloride 0.9% or glucose 5% over 20 minutes; four cycles to be given in total prior to formal re-staging.

Interventions

Vinflunine

All patients will receive on Day 1 of a 21 day cycle, vinflunine 320mg/m2 via intravenous infusion in either 100ml sodium chloride 0.9% or glucose 5% over 20 minutes; four cycles to be given in total prior to formal re-staging.

Intervention Type: DRUG

Other Intervention Names

Javlor

Eligibility Criteria

Inclusion Criteria

1. Male, ≥18 years.

2. Measurable disease as determined by RECIST (Response Evaluation Criteria in Solid Tumors) criteria (version 1.1).

3. Patients who present with purely cutaneous measurable disease should fulfill RECIST Criteria (see Appendix 1). Lesions should be a minimum size of 10 mm and measured using calipers by clinical examination.

4. Histologically-proven squamous cell carcinoma of the penis.

5. Stage: M1, or; M0, any T, N3 (i.e. involvement of deep inguinal or pelvic lymph nodes) or; M0, any T, N2 (i.e. involvement of multiple or bilateral superficial lymph nodes) or; M0, T4 (tumour invades other adjacent structures) any N.

Notes:

1. Patients with M0 disease may be considered if, in the opinion of the specialist Multi Disciplinary Team (MDT), they are deemed unlikely to benefit from surgery with curative intent and unlikely to tolerate combination chemotherapy due to comorbidities and/or disease burden.

2. Patients who have received prior radiotherapy to non-target lesions may be included.

6. Pre-treatment blood counts, haematology and biochemistry values within the following acceptable limits: Absolute Neutrophil Count (ANC) ≥ 1,500/mm3, Platelets ≥100,000/mm3, glomerular filtration rate (GFR) ≥60ml/min. GFR to be assessed according to local practice (recommended technique of eGFR using the MDRD formula.

7. Liver function: Patients must have (with or without the presence of liver metastases):

• A prothrombin time >70% normal value (NV) AND
• Bilirubin <1.5xUpper Limit of Normal (ULN) AND
• Transaminases <2.5xULN AND
• GGT <5xULN

8. Performance Status Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2.

9. Written, informed consent.

Exclusion Criteria

1. Pure verrucous carcinoma of the penis.

2. Squamous carcinoma of the urethra.

3. Patients who do not have measurable disease as determined by RECIST (version 1.1).

4. T1 N1 M0 disease.

5. T2 N1 M0 disease.

6. M0, T3, N1 (tumour invades urethra or prostate and single inguinal node involved).

7. Unfit for vinflunine chemotherapy (as assessed by the multidisciplinary team).

8. Previous chemotherapy or chemoradiotherapy.

9. Contraindication to chemotherapy.

10. Other malignancy (other than Squamous Cell Carcinoma or Basal Cell Carcinoma of non-penile skin) that has required surgical or non-surgical treatment in the last 5 years. All patients with a previous cancer diagnosis must be discussed the Chief Investigator prior to entry into the trial.

11. Patients who have received radiotherapy to target lesions and have no other lesions that can act as target lesions instead:

e.g. Patients with recurrent pelvic lymph nodes that are deemed irresectable and who have had prior radiotherapy to those lymph nodes:

i. are INELIGIBLE if the involved lymph nodes are the only site of disease.

ii. are ELIGIBLE if they have other measurable sites of disease e.g. pulmonary metastases.

If uncertain, please discuss with the Chief Investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

St George's Healthcare NHS Trust

OTHER

Sponsor Role: collaborator

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Pickering, MBBS, MRCP

Role: PRINCIPAL_INVESTIGATOR

St George's Healthcare NHS Trust

Locations

Velindre NHS Trust

Whitchurch, Cardiff, United Kingdom

Royal Cornwall Hospitals NHS Trust

Truro, Cornwall, United Kingdom

University College London Hospitals NHS Foundation Trust

London, Greater London, United Kingdom

The Christie NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

St George's Healthcare NHS Trust

Tooting, London, United Kingdom

Clatterbridge Centre for Oncology NHS Foundation Trust

Metropolitan Borough of Wirral, Merseyside, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

St James's University Hospital

Leeds, , United Kingdom

Leicester Royal Infirmary

Leicester, , United Kingdom

Countries

United Kingdom

References

Nicholson S, Tovey H, Elliott T, Burnett SM, Cruickshank C, Bahl A, Kirkbride P, Mitra AV, Thomson AH, Vasudev N, Venugopal B, Slade R, Tregellas L, Morgan B, Hassall A, Hall E, Pickering LM. VinCaP: a phase II trial of vinflunine in locally advanced and metastatic squamous carcinoma of the penis. Br J Cancer. 2022 Jan;126(1):34-41. doi: 10.1038/s41416-021-01574-9. Epub 2021 Oct 20.

Reference Type: DERIVED

PMID: 34671131 (View on PubMed)

Other Identifiers

CRUK/12/021

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2012-002592-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13/LO/0822

Identifier Type: OTHER

Identifier Source: secondary_id

CCR3858

Identifier Type: OTHER

Identifier Source: secondary_id

ICR-CTSU/2012/10036

Identifier Type: -

Identifier Source: org_study_id