A Phase 2 interventional study of ABI-007 and Carboplatin in Bladder Cancer, sponsored by University of Michigan Rogel Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-30.
Sponsored by University of Michigan Rogel Cancer Center · Phase 2, Interventional, and Treatment
Study participants will have been diagnosed with bladder cancer that has invaded the muscle wall of the bladder. Surgery is used to remove cancer when it is in the muscle of the bladder. Unfortunately, approximately 50% of people may have their cancer return in another location. For this reason, researchers are focusing on new chemotherapy regimens to be given before surgery (to remove the bladder) that may decrease the likelihood of cancer spreading.
Paclitaxel, carboplatin and gemcitabine are chemotherapy drugs known to destroy bladder cancer cells.
ABI-007 (brand name Abraxane™) is a form of the chemotherapy drug called paclitaxel. Standard paclitaxel is formulated with ethanol and a substance called Cremophor EL (polyoxyethylated castor oil). However, these additives are felt to contribute to the side effects (possibly severe) associated with paclitaxel. ABI-007 does not contain these additives and may deliver more drug to tumor cells. ABI-007 is approved by the United States Food and Drug Administration (FDA) in the treatment of metastatic (advanced) breast cancer, and is being evaluated in other cancers in research studies.
This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin and gemcitabine in the treatment of bladder cancer prior to surgery to remove the bladder.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 29 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Neoadjuvant ABI-007 (260 mg/m\^2) on day 1, Carboplatin (Target AUC \[Area under the curve\] =5) on day 1, and Gemcitabine (800 mg\^m2) on days 1 and 8, every 21 days.
Drug: ABI-007 · Drug: Carboplatin · Drug: Gemcitabine · Procedure: Radical Cystectomy
ABI-007 will be administered at a dose of 260 mg/m2 over a 30 min IV infusion on day 1 of each 21 day cycle.
Carboplatin will be administered at a dose of TARGET AUC=5 over a 15 min IV infusion of day 1 of each 21 day cycle.
Gemcitabine will be administered at a dose of 800 mg/m2 over a 30 min IV infusion on days 1 and 8 of each 21 day cycle.
Percentage of Patients With Complete Pathologic Response After 3 Cycles of Treatment
The rate of pathologic complete response (pT0) following three 21 day cycles of neoadjuvant ABI-007, carboplatin and gemcitabine was determined.
Time frame: 63 days (post 3 cycles)
| Milestone | Neoadjuvant ABI-007, Carboplatin, and Gemcitabine |
|---|---|
| Started | 29 |
| Completed | 22 |
| Not completed | 7 |
| Withdrew: Received different abi-007 schedule | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Patient declined surgery | 1 |
| Withdrew: Patient had unresectable disease | 1 |
| Withdrew: Death | 1 |
The rate of pathologic complete response (pT0) following three 21 day cycles of neoadjuvant ABI-007, carboplatin and gemcitabine was determined.
| percentage of patients | Neoadjuvant ABI-007, Carboplatin, and Gemcitabine |
|---|---|
| Percentage of Patients With Complete Pathologic Response After 3 Cycles of Treatment | 27.3 (10.7 to 50.2) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Neoadjuvant ABI-007, Carboplatin, and Gemcitabine | — | 26/29 (89.7%) | 29/29 (100%) |
| Event | Neoadjuvant ABI-007, Carboplatin, and Gemcitabine |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 22/29 |
| ThrombocytopeniaBlood and lymphatic system disorders | 9/29 |
| Febrile neutropeniaBlood and lymphatic system disorders | 4/29 |
| AnemiaBlood and lymphatic system disorders | 1/29 |
| DehydrationGastrointestinal disorders | 1/29 |
| Hemorrhage, CNSNervous system disorders | 1/29 |
| Infection with Grade 3 or 4 neutrophilsInfections and infestations | 1/29 |
| Infection with normal ANC or Grade 1 or 2 neutrophilsInfections and infestations | 1/29 |
| Adult Respiratory Distress Syndrome (ARDS)Respiratory, thoracic and mediastinal disorders | 1/29 |
| Renal failureRenal and urinary disorders | 1/29 |
| Event | Neoadjuvant ABI-007, Carboplatin, and Gemcitabine |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 25/29 |
| ThrombocytopeniaBlood and lymphatic system disorders | 25/29 |
| Fatigue (asthenia, lethargy, malaise)General disorders | 25/29 |
| Hair loss/alopecia (scalp or body)Skin and subcutaneous tissue disorders | 22/29 |
| AnemiaBlood and lymphatic system disorders | 19/29 |
| LeukopeniaBlood and lymphatic system disorders | 19/29 |
| Neuropathy: sensoryNervous system disorders | 17/29 |
| NauseaGastrointestinal disorders | 15/29 |
| AnorexiaGastrointestinal disorders | 11/29 |
| DiarrheaGastrointestinal disorders | 9/29 |
| Age, Continuous(years) | Neoadjuvant ABI-007, Carboplatin, and Gemcitabine |
|---|---|
| Median | 66 (38 to 82) |
| Sex: Female, Male(Participants) | Neoadjuvant ABI-007, Carboplatin, and Gemcitabine |
|---|---|
| Female | 7 |
| Male | 22 |
| Performance Status (ECOG)(participants) | Neoadjuvant ABI-007, Carboplatin, and Gemcitabine |
|---|---|
| 0 | 17 |
| 1 | 12 |
| Clinical Disease Stage(participants) | Neoadjuvant ABI-007, Carboplatin, and Gemcitabine |
|---|---|
| T2N0 | 18 |
| T2N1 | 2 |
| T2N2 | 1 |
| T3N0 | 6 |
| T4N0 | 2 |
| Hydronephrosis Present(participants) | Neoadjuvant ABI-007, Carboplatin, and Gemcitabine |
|---|---|
| Yes | 8 |
| No | 21 |
| Angiolymphatic Invasion Present(participants) | Neoadjuvant ABI-007, Carboplatin, and Gemcitabine |
|---|---|
| Yes | 9 |
| No | 20 |
| Adjacent Carcinoma in Situ Present(participants) | Neoadjuvant ABI-007, Carboplatin, and Gemcitabine |
|---|---|
| Yes | 16 |
| No | 13 |
| Mixed Histological Features Present(participants) | Neoadjuvant ABI-007, Carboplatin, and Gemcitabine |
|---|---|
| 70% Plasmacytoid, 5% Sarcomatoid | 1 |
| 10% Plasmacytoid, 10% Signet Ring | 1 |
| 5% Squamous | 1 |
| 10% Spindle | 1 |
| 20% Glandular | 1 |
| Nested | 3 |
| Micropapillary | 1 |
| Micropapillary and Nested | 1 |
| None | 19 |
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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University of Michigan Rogel Cancer Center