A Phase 2 interventional study of Avastin and Doxorubicin in Sarcoma and Soft Tissue Sarcoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-08.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 2, Interventional, and Treatment
This research is being done to find out if adding a drug called Avastin to an already approved regimen used for soft-tissue sarcoma, Doxorubicin, will improve overall survival, and slow disease progression. The study will also evaluate the overall safety of combining these drugs. It is not known if combining these drugs will improve outcome. Avastin has been approved for the treatment of metastatic carcinoma of the colon or rectum. It is not approved for the treatment of soft-tissue sarcoma when added to Doxorubicin.
The rationale for this trial is to improve the efficacy of prototypical anti-sarcoma chemotherapeutic regimen Doxorubicin when combined with Avastin®. Soft tissue sarcomas are highly vascular tumors and are therefore ideally suited to trials combining angiogenic inhibitors with chemotherapy. Several studies have revealed correlations between prognosis and surrogates for angiogenesis, including microvessel density, and circulating VEGF and basic fibroblast growth factor (bFGF). The aim of this study is to evaluate the safety and efficacy of Avastin® in combination with Doxorubicin for the treatment of advanced soft-tissue sarcomas.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 4 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.
Drug: Avastin · Drug: Doxorubicin
Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.
Also known as: bevacizumab
The Day 1 6- hour continuous IV infusion must be done through a central venous catheter.
Also known as: Adriamycin
RECIST
Study was terminated because of low accrual.
Time frame: 6 month PFS
Only 4 subjects were accrued over 2 years. Study was closed due to slow accrual.
| Milestone | Avastin and Doxorubicin |
|---|---|
| Started | 6 |
| Completed | 4 |
| Not completed | 2 |
Study was terminated because of low accrual.
No measurements were reported for this outcome.
Collected over none, study was terminated early because of low accrual.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Avastin and Doxorubicin | — | 2/4 (50%) | 1/4 (25%) |
| Event | Avastin and Doxorubicin |
|---|---|
| febrile neutropeniaBlood and lymphatic system disorders | 1/4 |
| acute renal failureRenal and urinary disorders | 1/4 |
| Event | Avastin and Doxorubicin |
|---|---|
| thrushInfections and infestations | 1/4 |
| dehydrationMetabolism and nutrition disorders | 1/4 |
| dysphagia -unable to swallow medicationsGastrointestinal disorders | 1/4 |
| Age, Continuous(years) | Avastin and Doxorubicin |
|---|---|
| Median | 58 (45 to 65) |
| Sex: Female, Male(Participants) | Avastin and Doxorubicin |
|---|---|
| Female | 2 |
| Male | 4 |
| Region of Enrollment(participants) | Avastin and Doxorubicin |
|---|---|
| United States | 6 |
This study is terminated, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins