Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00520403
Other study ID # ML19983
Secondary ID
Status Completed
Phase Phase 2
First received August 23, 2007
Last updated October 9, 2014
Start date September 2007
Est. completion date March 2010

Study information

Verified date October 2014
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Germany: Landesamt fur Gesundheit und Soziales Berlin
Study type Interventional

Clinical Trial Summary

This single arm study will assess the efficacy and safety of Avastin in combination with interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3 times weekly (3 Mio IU sc escalating to 18 Mio sc) and vinblastine (0.1mg/kg iv) every 3 weeks. The anticipated time on study treatment is until tumor progression, and the target sample size is 100-500 individuals.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adult patients, >=18 years of age;

- metastatic renal cell cancer of predominantly clear cell type;

- >=1 measurable lesion.

Exclusion Criteria:

- prior treatment with chemotherapy, cytokine or tyrosine kinase inhibitor therapy for metastatic renal cell cancer;

- ongoing or recent need for full therapeutic dose of anticoagulants or chronic daily treatment with aspirin (>325mg/day);

- clinically significant cardiovascular disease.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
bevacizumab [Avastin]
15mg/kg iv every 3 weeks
Interferon alfa-2a
3 MioIU sc escalating to 18 MioIU sc, 3 times weekly
Vinblastine
0.1mg/kg iv every 3 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Disease Progression or Death Disease progression was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) using computed tomography (CT) scans (preferred method), magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination. Days 0, 91, 182, 273, 365, 456, and 547 No
Primary PFS - Time to Event PFS was defined as the time in days from the date of treatment start to the date of first documented disease progression or death. Disease progression was evaluated according to RECIST using CT scans (preferred method), MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method Days 0, 91, 182, 273, 365, 456, and 547 No
Secondary Percentage of Participants With Objective Response (OR) Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to RECIST. Baseline and Cycles 3, 6, 9, 13, and 17 No
Secondary Overall Survival (OS) OS was defined as the duration from treatment start to death from any cause. Overall survival was censored at the last contact for surviving participants and missing data points. Baseline, Day 1 of every cycle to disease progression or death (up to Week 102) No
See also
  Status Clinical Trial Phase
Completed NCT01392729 - An Observational Study of Avastin (Bevacizumab) and Interferon Alpha 2a in Patients With Metastatic Renal Cell Cancer (VERA) N/A
Completed NCT00694096 - Sunitinib for Metastatic Renal Cell Cancer With Imaging Biomarker Assessments for the Early Prediction of Tumor Response Phase 1
Completed NCT00216801 - Relationship of Ochratoxin A to Upper Urologic Cancers N/A
Completed NCT00172003 - Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis Phase 4
Completed NCT02493751 - A Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100) Phase 1
Recruiting NCT01967407 - IReversible Electroporation of Kidney Tumors Before Partial Nephrectomy. Phase 1/Phase 2
Completed NCT00509704 - Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma N/A
Terminated NCT05061537 - Study of PF-07263689 in Participants With Selected Advanced Solid Tumors Phase 1
Completed NCT04535921 - Fear of Cancer Recurrence in Genitourinary Cancer
Recruiting NCT04620603 - Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer Phase 1/Phase 2
Completed NCT01829841 - A Study of Famitinib in Patients With Advanced Metastatic Renal Cell Cancer Phase 2
Completed NCT01122615 - Sunitinib Plus Temsirolimus in Patients With Renal Cell Cancer (RCC) Phase 1
Completed NCT00979329 - Study on the Influence of Sunitinib and Sorafenib on Fatigue, QoL, Depression in Patients With Metastatic RCC or GIST N/A
Active, not recruiting NCT02429440 - Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides Phase 1/Phase 2
Recruiting NCT06362369 - A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy Phase 1/Phase 2
Active, not recruiting NCT02684006 - A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) Phase 3
Completed NCT02375776 - Improving Outcomes in Cancer Patients on Oral Anti-Cancer Medications Using a Multi-modal Mobile Health Intervention N/A
Completed NCT01598597 - An Observational Pilot Study Evaluating the Feasibility of Conducting Genome-Wide Association Studies Utilizing Subject Provided Information in Subjects With Locally Recurrent or MBC, MCRC, MNSCLC, RGBM or MRCC Treated With Avastin (Bevacizumab) (InVite) N/A
Completed NCT00465179 - Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer Phase 2
Completed NCT01158534 - Celecoxib and Recombinant Interferon Alfa-2b in Metastatic Kidney Cancer Who Have Undergone Surgery Phase 2