A Phase 2 interventional study of bevacizumab and laboratory biomarker analysis in Cervical Squamous Cell Carcinoma and Recurrent Cervical Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-24.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
This phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent cancer of the cervix. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.
OBJECTIVES:
I. Determine the cytostatic antitumor activity of bevacizumab, in terms of 6-month progression-free survival (PFS), in patients with persistent or recurrent squamous cell carcinoma of the cervix.
II. Determine the nature and degree of toxicity of this drug in these patients. III. Estimate the distribution of PFS and overall survival for patients treated with this drug.
IV. Determine the frequency of clinical response (partial and complete) in patients treated with this drug.
V. Determine the role of age and initial performance status as prognostic factors in patients treated with this drug.
VI. Determine whether biological and imaging markers are associated with clinical efficacy of this drug, such as 6-month PFS, in these patients.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-38 months.
1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.
This study's enrollment of 50 is below the median of 100 across 1,411 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,554 studies on the registry; 334 are open to participants now.
Of its 407 completed or terminated interventional studies of FDA-regulated products, 370 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Patients must have received at least 1, but no more than 2, prior cytotoxic chemotherapy regimens for advanced, metastatic, or recurrent SCC of the cervix
At least 1 unidimensionally measurable lesion*
No proteinuria
Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Biological: bevacizumab · Other: laboratory biomarker analysis
Given IV
Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Correlative studies
Progression-free Survival Greater Than 6 Months
Whether or not the patient survived progression-free for at least 6 months.
Time frame: Every other 3-week treatment cycle for 6 months
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
The maximum severity of each adverse event per patient, graded according to Common Toxicity Criteria version 2.0, is reported. Events were restricted to those reported as at least possibly related to study drug.
Time frame: Every cycle and 30 days after the end of treatment. (average 5 months)
Tumor Response
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Time frame: Every other cycle during treatment and at the time of treatment discontinuation. (average 5 months)
Overall Survival
The observed length of life from entry into the study to death or the date of last contact.
Time frame: From study entry to death or last contact, up to 5 years.
Duration of Progression-free Survival
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Time frame: Every other cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years
Performance Status
Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.
Time frame: Baseline
Age at Enrollment
Time frame: Baseline
The study was activated on 4/29/2002 and closed to accrual on 11/6/2006 (suspended from 2/7/2005 to 10/30/2005).
| Milestone | Bevacizumab |
|---|---|
| Started | 50 |
| Completed | 46 |
| Not completed | 4 |
| Withdrew: Ineligible: wrong cell type | 1 |
| Withdrew: Ineligible: wrong primary | 1 |
| Withdrew: Ineligible: improper prior treatment | 1 |
| Withdrew: Never treated | 1 |
Whether or not the patient survived progression-free for at least 6 months.
| percentage of participants | Bevacizumab |
|---|---|
| Progression-free Survival Greater Than 6 Months | 23.9 (14.0 to 36.5) |
The maximum severity of each adverse event per patient, graded according to Common Toxicity Criteria version 2.0, is reported. Events were restricted to those reported as at least possibly related to study drug.
| Participants | Grade 0 | Grade 1 (CTCAE v 2.0) | Grade 2 (CTCAE v 2.0) | Grade 3 (CTCAE v 2.0) | Grade 4 (CTCAE v 2.0) | Grade 5 (CTCAE v 2.0) |
|---|---|---|---|---|---|---|
| Leukopenia | 39 | 3 | 3 | 1 | 0 | 0 |
| Thrombocytopenia | 43 | 3 | 0 | 0 | 0 | 0 |
| Neutropenia | 42 | 2 | 1 | 1 | 0 | 0 |
| Anemia | 26 | 8 | 10 | 2 | 0 | 0 |
| Other hematologic | 41 | 1 | 0 | 4 | 0 | 0 |
| Allergy | 45 | 1 | 0 | 0 | 0 | 0 |
| Hypertension | 33 | 4 | 2 | 7 | 0 | 0 |
| Thrombosis Embolism | 41 | 0 | 0 | 4 | 1 | 0 |
| Other cardiovascular | 34 | 8 | 2 | 2 | 0 | 0 |
| Coagulation | 43 | 2 | 0 | 1 | 0 | 0 |
| Constitutional | 22 | 16 | 6 | 2 | 0 | 0 |
| Dermatologic | 36 | 5 | 5 | 0 | 0 | 0 |
| Gastrointestinal | 25 | 7 | 10 | 3 | 1 | 0 |
| Genitourinary/renal | 34 | 6 | 3 | 2 | 1 | 0 |
| Hemorrhage | 38 | 5 | 2 | 0 | 1 | 0 |
| Hepatic | 35 | 11 | 0 | 0 | 0 | 0 |
| Infection | 40 | 0 | 3 | 2 | 0 | 1 |
| Metabolic | 29 | 16 | 0 | 1 | 0 | 0 |
| Neuropathy sensory | 41 | 3 | 2 | 0 | 0 | 0 |
| Other neurologic | 41 | 2 | 3 | 0 | 0 | 0 |
| Pain | 27 | 8 | 5 | 6 | 0 | 0 |
| Pulmonary | 38 | 1 | 5 | 2 | 0 | 0 |
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
| percentage of participants | Bevacizumab |
|---|---|
| Tumor Response | 10.9 (4.4 to 21.5) |
The observed length of life from entry into the study to death or the date of last contact.
| months | Bevacizumab |
|---|---|
| Overall Survival | 7.3 (6.1 to 10.4) |
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
| months | Bevacizumab |
|---|---|
| Duration of Progression-free Survival | 3.40 (2.53 to 4.53) |
Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.
| Participants | Bevacizumab |
|---|---|
| Performance Status 0 | 22 |
| Performance Status 1 | 23 |
| Performance Status 2 | 1 |
| Participants | Bevacizumab |
|---|---|
| 20-29 years | 1 |
| 30-39 years | 11 |
| 40-49 years | 17 |
| 50-59 years | 12 |
| 60-69 years | 5 |
Collected over All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bevacizumab | — | 27/46 (58.7%) | 46/46 (100%) |
| Event | Bevacizumab |
|---|---|
| Thrombosis EmbolismCardiac disorders | 5/46 |
| Constitutional Symptoms OtherGeneral disorders | 4/46 |
| ConstipationGastrointestinal disorders | 3/46 |
| FatigueGeneral disorders | 2/46 |
| Abdominal PainGeneral disorders | 2/46 |
| Vaginal BleedingVascular disorders | 2/46 |
| Pelvic PainGeneral disorders | 2/46 |
| Renal/Gu OtherRenal and urinary disorders | 2/46 |
| Ureteral ObstructionRenal and urinary disorders | 2/46 |
| AnemiaBlood and lymphatic system disorders | 1/46 |
| Event | Bevacizumab |
|---|---|
| FatigueGeneral disorders | 34/46 |
| AnemiaBlood and lymphatic system disorders | 33/46 |
| Abdominal PainGeneral disorders | 21/46 |
| ConstipationGastrointestinal disorders | 21/46 |
| Pain OtherGeneral disorders | 19/46 |
| AnorexiaGastrointestinal disorders | 19/46 |
| NauseaGastrointestinal disorders | 19/46 |
| HyperglycemiaMetabolism and nutrition disorders | 19/46 |
| Infection Without NeutropeniaInfections and infestations | 17/46 |
| Neuropathy SensorMusculoskeletal and connective tissue disorders | 16/46 |
Eligible and treated patients.
| Age, Continuous(years) | Bevacizumab |
|---|---|
| Mean | 46.4 ± 9.3 |
| Age, Customized(participants) | Bevacizumab |
|---|---|
| 20-29 years | 1 |
| 30-39 years | 11 |
| 40-49 years | 17 |
| 50-59 years | 12 |
| 60-69 years | 5 |
| Sex: Female, Male(Participants) | Bevacizumab |
|---|---|
| Female | 46 |
| Male | 0 |
| Region of Enrollment(participants) | Bevacizumab |
|---|---|
| United States | 45 |
| Canada | 1 |
| Histologic Type(participants) | Bevacizumab |
|---|---|
| Adenosquamous | 3 |
| Squamous Cell Carcinoma | 43 |
| International Federation of Gynecology and Obstetrics (FIGO) Stage(participants) | Bevacizumab |
|---|---|
| Unspecified | 1 |
| Recurrent/Persistent | 45 |
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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