A Phase 2 interventional study of Doxil and Avastin in Ovarian Cancer, sponsored by New Mexico Cancer Research Alliance. Completed at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-31.
Sponsored by New Mexico Cancer Research Alliance · Phase 2, Interventional, and Treatment
The purpose of this research study is to test the safety, tolerability, and effectiveness of two chemotherapy drugs, pegylated liposomal doxorubicin (Doxil) and bevacizumab (Avastin). How Doxil is metabolized and excreted from the body will also be studied.
Avastin:
Avastin is a humanized monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer). Avastin has been approved for the treatment of colorectal cancer and lung cancer. Avastin is investigational for the treatment of ovarian cancer and has not been approved by the United States Food and Drug Administration (FDA) for this use.
Avastin is thought to work by attaching to a protein called vascular endothelial growth factor (VEGF) to block its action. VEGF plays a role in the formation of both normal and abnormal blood vessels. It is present in normal tissues, but is produced in excess by most solid cancers (tumors). In cancer, VEGF helps blood vessels bring nutrients to tumor cells, allowing the tumor cells to grow. In laboratory studies with human cancer cells grown in animals, Avastin has been shown to prevent or slow the growth of different types of cancer cells by blocking the effects of VEGF.
Doxorubicin:
Doxorubicin is a type of antibiotic that is only used in cancer chemotherapy. It slows or stops the growth of cancer. Doxorubicin has been approved by the FDA to treat cancers of the head, neck, cervix, vagina, testes, prostate, uterus and Ewing's tumor.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 46 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →New Mexico Cancer Research Alliance is the lead sponsor of 70 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be included in the study based on the following criteria:
Exclusion Criteria:
Disease-Specific Exclusions:
General Medical Exclusions:
Avastin-Specific Exclusions
Proteinuria at screening as demonstrated by either:
Patients receive both agents, doxil and Avastin.
Drug: Doxil · Drug: Avastin
Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1
Also known as: Doxorubicin
First agent (Doxil) will be following by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression
Also known as: Bevacizumab
Progression Free Survival (PFS) by RECIST Criteria
Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by hysical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: Up to 25 months
Progression Free Survival (PFS) by GCIC Criteria
Using GCIC criteria, progression is defined as CA-125 levels greater than, or equal to, 2 times the upper limit of a reference range on 2 occasions and at least 1 week apart.
Time frame: Up to 25 months
Overall Survival
The time from treatment initiation to death by any cause
Time frame: 4 years
Overall Response Rate (ORR) by RECIST
ORR is the sum of the percentages of patients achieving complete and partial responses. Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0)
Time frame: 3 years
Clinical Benefit Rate (by RECIST)
Clinical Benefit Rate (CBR) is the sum of the percentages of patients achieving complete response, partial response, and stable disease. Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: 3 years
Overall Response Rate (ORR) by GCIC Criteria
A response according to GCIC criteria has occurred if there is at least a 50% reduction in CA 125 levels from a pretreatment sample. The response must be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they have a pretreatment sample that is at least twice the upper limit of normal and within 2 weeks prior to starting treatment.
Time frame: 3 years
A total of 60 patients were screened for this study at all sites beginning March 2007. 46 patients were enrolled at the UNM Cancer Center, NYU Medical Center and NM Cancer Care Associates/Santa Fe.
| Milestone | Doxil (PLD) + Avastin (Bevacizumab) |
|---|---|
| Started | 46 |
| Completed | 46 |
| Not completed | 0 |
Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by hysical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
| Months | Doxil (PLD) + Avastin (Bevacizumab) |
|---|---|
| Progression Free Survival (PFS) by RECIST Criteria | 7.8 (2 to 13.3) |
The time from treatment initiation to death by any cause
| Months | Doxil (PLD) + Avastin (Bevacizumab) |
|---|---|
| Overall Survival | 33.2 (3 to 37.5) |
ORR is the sum of the percentages of patients achieving complete and partial responses. Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0)
| Percentage of participants | Doxil (PLD) + Avastin (Bevacizumab) |
|---|---|
| Complete Response (CR) | 9 (3 to 22) |
| Partial Response (PR) | 21 (10 to 36) |
| Overall Response Rate (ORR) | 30 (17 to 46) |
Clinical Benefit Rate (CBR) is the sum of the percentages of patients achieving complete response, partial response, and stable disease. Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
| percentage of participants | Doxil (PLD) + Avastin (Bevacizumab) |
|---|---|
| Complete Response (CR) | 9 (3 to 22) |
| Partial Response (PR) | 21 (10 to 36) |
| Stable Disease (SD) | 56 (40 to 71) |
| Clinical Benefit Rate (CBR) | 86 (72 to 95) |
A response according to GCIC criteria has occurred if there is at least a 50% reduction in CA 125 levels from a pretreatment sample. The response must be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they have a pretreatment sample that is at least twice the upper limit of normal and within 2 weeks prior to starting treatment.
| percentage of participants | Doxil (PLD) + Avastin (Bevacizumab) |
|---|---|
| Overall Response Rate (ORR) by GCIC Criteria | 50 (31 to 69) |
Using GCIC criteria, progression is defined as CA-125 levels greater than, or equal to, 2 times the upper limit of a reference range on 2 occasions and at least 1 week apart.
| Months | Doxil (PLD) + Avastin (Bevacizumab) |
|---|---|
| Progression Free Survival (PFS) by GCIC Criteria | 6.6 (1 to 24.6) |
Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Doxil (PLD) + Avastin (Bevacizumab) | — | 3/46 (6.5%) | 45/46 (97.8%) |
| Event | Doxil (PLD) + Avastin (Bevacizumab) |
|---|---|
| NauseaGastrointestinal disorders | 1/46 |
| VomitingGastrointestinal disorders | 1/46 |
| DehydrationGastrointestinal disorders | 1/46 |
| Bladder InfectionInfections and infestations | 1/46 |
| Muscle weaknessMusculoskeletal and connective tissue disorders | 1/46 |
| Cognitive disturbanceNervous system disorders | 1/46 |
| HeadacheNervous system disorders | 1/46 |
| Speech impairment: global aphasiaNervous system disorders | 1/46 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/46 |
| Esophagoscopy abnormal: ulcerationGastrointestinal disorders | 1/46 |
| Event | Doxil (PLD) + Avastin (Bevacizumab) |
|---|---|
| FatigueGeneral disorders | 23/46 |
| Hand-and-foot syndromeSkin and subcutaneous tissue disorders | 21/46 |
| HeadacheNervous system disorders | 20/46 |
| Hypertension (High blood pressure)Cardiac disorders | 18/46 |
| NauseaGastrointestinal disorders | 17/46 |
| RashSkin and subcutaneous tissue disorders | 15/46 |
| ConstipationGastrointestinal disorders | 15/46 |
| Abdominal painGastrointestinal disorders | 14/46 |
| Ear, nose and throat examination abnormalGeneral disorders | 14/46 |
| Dry skinSkin and subcutaneous tissue disorders | 12/46 |
| Age, Categorical(Participants) | Doxil (PLD) + Avastin (Bevacizumab) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 36 |
| Sex: Female, Male(Participants) | Doxil (PLD) + Avastin (Bevacizumab) |
|---|---|
| Female | 46 |
| Male | 0 |
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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New Mexico Cancer Research Alliance