Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Disease Progression

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Bevacizumab

Interferons

Interferon-alpha

Interferon alpha-2

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antiviral Agents

Immunologic Factors

bevacizumab [Avastin]

interferon alfa-2a

Clinical Trials

This single arm study will assess progression free survival, tumor response and safety of Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with metastatic clear cell renal cell carcinoma. Patients will receive Avastin (10mg/kg iv) every 2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week (t.i.w.). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).

An Open Label Study of the Effect of First Line Treatment With Avastin (Bevacizumab) in Combination With Low-dose Interferon on Progression-free Survival in Patients With Metastatic Clear Cell Renal Cell Carcinoma.

PFS at 12 and 24 months is an estimate of the percentages of participants expected to be progression free at 12 and 24 months based on Kaplan-Meier survival analysis of the PFS data. PFS was defined as the time period from the first postbaseline tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.

PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.

Percentage of participants with objective response, termed responders, based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study greater than or equal to (≥)4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than \[\<\]10 millimeters \[mm\]). No new lesions. PR was defined as ≥30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

OS at 12 and 24 months is the estimate of the percentages of participants expected to alive at 12 and 24 months based on Kaplan-Meier survival analysis of the survival data. Median OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.

OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.

EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). Answers from the questionnaire for each dimension (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) was classified into one of 2 categories: 'no problems' or 'any problems', and the percentage of participants in each category was determined.

EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 millimeters (mm) (best imaginable health state); higher scores indicate a better health state. Participants were asked to rate their health state and mark the line; the distance from the left edge was recorded. For change from baseline a negative value represents a worsening in the health state and a positive value represents an improvement in the health state.

Hoffmann-La Roche

All Grade \>3 AEs documented. Only Grade 1/2 AEs related to bevacizumab and/or IFN occurring from first bevacizumab administration up to 28 days after last dose were documented.

Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.

Bevacizumab + Interferon

Age, Continuous

Sex: Female, Male

Intent-to-treat (ITT) population: All participants who received at least 1 dose of either or both study drugs and had a valid baseline assessment and at least 1 postbaseline assessment.

Medical Communications

12 months

24 months

Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months

ITT population; only participants with measurable disease were included in the analysis.

Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR)

PFS - Percentage of Participants With an Event

PFS - Time to Event

Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months

OS - Percentage of Participants With an Event

OS - Time to Event

Mobility, no problems, Baseline (n=142)

Mobility, any problems, Baseline (n=142)

Mobility, no problems, Cycle 7 (n=106)

Mobility, any problems, Cycle 7 (n=106)

Mobility, no problems, Cycle 25 (n=69)

Mobility, any problems, Cycle 25 (n=69)

Mobility, no problems, Cycle 43 (n=36)

Mobility, any problems, Cycle 43 (n=36)

Mobility, no problems, Cycle 61 (n=22)

Mobility, any problems, Cycle 61 (n=22)

Mobility, no problems, EOT (n=82)

Mobility, any problems, EOT (n=82)

Self-care, no problems, Baseline (n=145)

Self-care, any problems, Baseline (n=145)

Self-care, no problems, Cycle 7 (n=106)

Self-care, any problems, Cycle 7 (n=106)

Self-care, no problems, Cycle 25 (n=69)

Self-care, any problems, Cycle 25 (n=69)

Self-care, no problems, Cycle 43 (n=36)

Self-care, any problems, Cycle 43 (n=36)

Self-care, no problems, Cycle 61 (n=22)

Self-care, any problems, Cycle 61 (n=22)

Self-care, no problems, EOT (n=80)

Self-care, any problems, EOT (n=80)

Usual activity, no problems, Baseline (n=145)

Usual activity, any problems, Baseline (n=145)

Usual activity, no problems, Cycle 7 (n=106)

Usual activity, any problems, Cycle 7 (n=106)

Usual activity, no problems, Cycle 25 (n=69)

Usual activity, any problems, Cycle 25 (n=69)

Usual activity, no problems, Cycle 43 (n=36)

Usual activity, any problems, Cycle 43 (n=36)

Usual activity, no problems, Cycle 61 (n=22)

Usual activity, any problems, Cycle 61 (n=22)

Usual activity, no problems, EOT (n=78)

Usual activity, any problems, EOT (n=78)

Pain/discomfort, no problems, Baseline (n=145)

Pain/discomfort, any problems, Baseline (n=145)

Pain/discomfort, no problems, Cycle 7 (n=106)

Pain/discomfort, any problems, Cycle 7 (n=106)

Pain/discomfort, no problems, Cycle 25 (n=69)

Pain/discomfort, any problems, Cycle 25 (n=69)

Pain/discomfort, no problems, Cycle 43 (n=36)

Pain/discomfort, any problems, Cycle 43 (n=36)

Pain/discomfort, no problems, Cycle 61 (n=22)

Pain/discomfort, any problems, Cycle 61 (n=22)

Pain/discomfort, no problems, EOT (n=80)

Pain/discomfort, any problems, EOT (n=80)

Anxiety/depression, no problems, Baseline (n=144)

Anxiety/depression, any problems, Baseline (n=144)

Anxiety/depression, no problems, Cycle 7 (n=106)

Anxiety/depression, any problems, Cycle 7 (n=106)

Anxiety/depression, no problems, Cycle 25 (n=69)

Anxiety/depression, any problems, Cycle 25 (n=69)

Anxiety/depression, no problems, Cycle 43 (n=36)

Anxiety/depression, any problems, Cycle 43 (n=36)

Anxiety/depression, no problems, Cycle 61 (n=22)

Anxiety/depression, any problems, Cycle 61 (n=22)

Anxiety/depression, no problems, EOT (n=80)

Anxiety/depression, any problems, EOT (n=80)

ITT population; number (n) equals (=) number of participants assessed for the specified parameter at a given visit.

Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit

Baseline (n=140)

Cycle 7 (n=103)

Change at Cycle 7 (n=99)

Cycle 25 (n=68)

Change at Cycle 25 (n=67)

Cycle 43 (n=36)

Change at Cycle 43 (n=36)

Cycle 61 (n=22)

Change at Cycle 61 (n=22)

EOT (n=79)

Change at EOT (n=77)

ITT population; n=number of participants assessed for the specified parameter at a given visit.

EQ-5D - Visual Analog Scale (VAS)

Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 and Interferon alpha-2a (IFN) 3 million international units (MIU) subcutaneously (SC) 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.

Bevacizumab Plus (+) Interferon

Overall Study

Spots Global Cancer Trial Database for A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial