A Phase 2 interventional study of Bevacizumab and Cisplatin in Esophageal Cancer, Gastric Cancer and Stomach Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by Dana-Farber Cancer Institute · Phase 2, Interventional, and Treatment
There is no clear standard of care for metastatic stomach or esophageal cancer in the United States. The purpose of this research study is to determine the differences between two regimens of chemotherapy; Arm A: PCA (Cisplatin, Irinotecan and Bevacizumab) and Arm B: TPCA (Docetaxel, Cisplatin, Irinotecan and Bevacizumab). Docetaxel, Cisplatin, and Irinotecan are traditional chemotherapy drugs. Bevacizumab is an antibody (a protein that attacks a foreign substance in the body). Bevacizumab is believed to stop the formation of new blood vessels that carry nutrients to tumors. Both of the chemotherapy regimens (PCA and TPCA) have been studied in patients with esophageal and gastric cancer, and we are trying to determine if one regimen will keep your cancer from growing and improve how long you can live.
OBJECTIVES:
Primary
* To evaluate progression-free survival at 7 months in metastatic esophageal and gastric patients treated with either PCA or TPCA
Secondary
Exploratory:
DESIGN:
This trial was designed to compare 7-month progression-free survival between arms. The hypothesis was that TPCA would have superior outcome over PCA (70% vs 50%). With 40 eligible patients per arm followed for 1 year there was 80% power to detect a hazard ratio of 0.48 using the log-rank test at a one-sided type I error rate of 5%. Stratification factors were ECOG performance status 0/1 vs 2 and site of primary tumor (gastric vs GE junction/esophageal).
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 88 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
Drug: Bevacizumab · Drug: Cisplatin · Drug: Irinotecan
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
Drug: Cisplatin · Drug: Irinotecan · Device: Docetaxel
Also known as: Avastin
Also known as: Platinol-AQ, Platinol
Also known as: Camptosar
Also known as: Taxotere, Docefrez
7-month Progression-Free Survival
7-month progression-free survival is the probability of patients remaining alive and progression-free at 7-months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Time frame: Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Relevant for this endpoint was disease status at 7 months of follow-up.
Overall Survival
Overall survival is defined as the time from study entry to death or date last known alive and estimate using Kaplan-Meier (KM) methods.
Time frame: Patients in the study cohort were followed up to approximately 2.5 years as of this analysis.
Best Response
Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria.
Time frame: Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis..
Overall Response (OR) Rate
Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Time frame: Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis.
Progression-Free Survival
Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Patients alive and progression-free at last follow-up are censored. Per RECIST 1.0 criteria: progressive disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Time frame: Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Patients were followed for up to 2.5 years as of this analysis.
Patients were enrolled between July 2009 and April 2011.
| Milestone | Arm A: PCA | Arm B: TPCA |
|---|---|---|
| Started | 45 | 43 |
| Treated | 44 | 41 |
| Completed | 0 | 0 |
| Not completed | 45 | 43 |
| Withdrew: Recist progression | 12 | 8 |
| Withdrew: Adverse event | 8 | 8 |
| Withdrew: Clinical progression | 7 | 5 |
| Withdrew: Physician decision | 5 | 9 |
| Withdrew: Decline in performance status | 4 | 2 |
| Withdrew: Withdrawal by subject | 3 | 4 |
| Withdrew: Death | 1 | 2 |
| Withdrew: Pursue surgery | 1 | 1 |
| Withdrew: Pursue radiation | 1 | 0 |
| Withdrew: Still on therapy | 2 | 2 |
| Withdrew: Pathology not confirmed | 1 | 0 |
| Withdrew: Withdraw before receive treatment | 0 | 2 |
7-month progression-free survival is the probability of patients remaining alive and progression-free at 7-months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
| probability | Arm A: PCA | Arm B: TPCA |
|---|---|---|
| 7-month Progression-Free Survival | 0.581 (0.421 to 0.712) | 0.582 (0.410 to 0.719) |
Overall survival is defined as the time from study entry to death or date last known alive and estimate using Kaplan-Meier (KM) methods.
| months | Arm A: PCA | Arm B: TPCA |
|---|---|---|
| Overall Survival | 11.7 (9.6 to 15.4) | 13.4 (11.5 to 16.1) |
Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria.
| Participants | Arm A: PCA | Arm B: TPCA |
|---|---|---|
| Complete Response | 3 | 0 |
| Partial Response | 22 | 21 |
| Stable Disease | 15 | 14 |
| Progressive Disease | 1 | 0 |
| Removed Before Restaging | 3 | 6 |
Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
| proportion of patients | Arm A: PCA | Arm B: TPCA |
|---|---|---|
| Overall Response (OR) Rate | .568 (.41 to .717) | .512 (.351 to .671) |
Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Patients alive and progression-free at last follow-up are censored. Per RECIST 1.0 criteria: progressive disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
| months | Arm A: PCA | Arm B: TPCA |
|---|---|---|
| Progression-Free Survival | 7.9 (6.1 to 10.1) | 8.4 (6.2 to 9.7) |
Collected over Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: PCA | 0/44 (0%) | 32/44 (72.7%) | 44/44 (100%) |
| Arm B: TPCA | 3/41 (7.3%) | 36/41 (87.8%) | 39/41 (95.1%) |
| Event | Arm A: PCA | Arm B: TPCA |
|---|---|---|
| Diarrhea w/o prior colostomyGastrointestinal disorders | 10/44 | 13/41 |
| NeutrophilsInvestigations | 11/44 | 13/41 |
| LeukocytesInvestigations | 6/44 | 11/41 |
| FatigueGeneral disorders | 7/44 | 9/41 |
| LymphopeniaInvestigations | 4/44 | 6/41 |
| DehydrationMetabolism and nutrition disorders | 6/44 | 5/41 |
| HyponatremiaMetabolism and nutrition disorders | 1/44 | 5/41 |
| NauseaGastrointestinal disorders | 4/44 | 5/41 |
| VomitingGastrointestinal disorders | 4/44 | 5/41 |
| HemoglobinBlood and lymphatic system disorders | 5/44 | 3/41 |
| Event | Arm A: PCA | Arm B: TPCA |
|---|---|---|
| FatigueGeneral disorders | 35/44 | 34/41 |
| NauseaGastrointestinal disorders | 35/44 | 31/41 |
| HemoglobinBlood and lymphatic system disorders | 34/44 | 28/41 |
| Diarrhea w/o prior colostomyGastrointestinal disorders | 31/44 | 29/41 |
| AnorexiaMetabolism and nutrition disorders | 19/44 | 28/41 |
| LeukocytesInvestigations | 23/44 | 23/41 |
| PlateletsInvestigations | 23/44 | 17/41 |
| VomitingGastrointestinal disorders | 22/44 | 21/41 |
| ConstipationGastrointestinal disorders | 21/44 | 18/41 |
| Abdomen, painGastrointestinal disorders | 17/44 | 19/41 |
The analysis dataset is comprised of all treated patients.
| Age, Continuous(years) | Arm A: PCA | Arm B: TPCA | Total |
|---|---|---|---|
| Median | 59 (41 to 79) | 61 (40 to 85) | 60 (40 to 85) |
| Sex: Female, Male(Participants) | Arm A: PCA | Arm B: TPCA | Total |
|---|---|---|---|
| Female | 8 | 7 | 15 |
| Male | 36 | 34 | 70 |
| Race (NIH/OMB)(Participants) | Arm A: PCA | Arm B: TPCA | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 2 |
| White | 41 | 39 | 80 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Region of Enrollment(Participants) | Arm A: PCA | Arm B: TPCA | Total |
|---|---|---|---|
| United States | 44 | 41 | 85 |
| ECOG Performance Status (PS)(Participants) | Arm A: PCA | Arm B: TPCA | Total |
|---|---|---|---|
| ECOG PS 0/1 | 43 | 40 | 83 |
| ECOG PS 2 | 1 | 1 | 2 |
| Tumor Location(Participants) | Arm A: PCA | Arm B: TPCA | Total |
|---|---|---|---|
| Esophagus | 20 | 17 | 37 |
| GE Junction | 9 | 12 | 21 |
| Gastric | 15 | 12 | 27 |
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Dana-Farber Cancer Institute