Colorectal Cancer
Conditions
Brief summary
The purpose of the study is to describe the tumor response rates for the two regimens being studied, and to determine how long patients live after receiving the treatment, how long patients are without return of their disease after they receive treatment, and how long the response they get from the treatment lasts. The amount and type of side effects/toxicities of each regimen will also be evaluated. The regimen including Oxaliplatin + 5FU/Folinic Acid is a current standard of care.
Interventions
DRUGGemcitabine
900 mg/m2 IV over 90 minutes after Folinic Acid weekly for 6 weeks every 8 weeks until progression.
DRUGavastin
5 milligrams per kilogram (mg/kg)
DRUG5FU/folinic acid
Folinic Acid: 100 milligrams per square meter (mg/m2) intravenous (IV) over 60 minutes (A+FFG). Folinic Acid: 200 mg/m2 as a 2-hr infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4). 5-Fluorouracil: 450 mg/m2 as an IV bolus in middle of Folinic Acid (A+FFG). 5-Fluorouracil: 400 mg/m2 bolus plus a 600 mg/m2 22-hour infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4).
DRUGoxaliplatin
85 mg/m2 as a 2-hour infusion on Day 1 of a 14 day cycle.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have a histological or cytological diagnosis of the colon or rectum with Stage III unresectable or Stage IV disease. * Urinalysis or Urine dipstick for proteinuria of less than 1+ (i.e. either 0 or trace). If urine dipstick is greater than 1+, the 24 hour urine protein must demonstrate less than 500 mg of protein in 24 hours to allow participation. * No prior chemotherapy, immunotherapy, or hormonal treatment for metastatic disease is acceptable. However, one prior neo-adjuvant or adjuvant treatment is acceptable, including Capecitabine, Camptothecin-11 (CPT-11), 5 Fluorouracil/Leucovorin (5FU/LV) or Radiation containing regimens, (but no Oxaliplatin), and only if progression \> 6 months since last adjuvant treatment. * Prior radiation therapy, including radiation to the whole pelvis, is allowed (Cristy and Eckerman 1987) and patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. Prior palliative radiation therapy given to a non-measurable diagnostic site is acceptable if given \> 4 weeks prior to treatment or if other non-irradiated measurable disease is present. * No known central nervous system (CNS) metastasis.
Exclusion criteria
* Histology other than adenocarcinoma * Tumors that demonstrate free perforation as manifested by free air or free fluid in the abdomen. Patients with walled-off perforation are eligible. * Gastroduodenal ulcer determined as active by endoscopy. * Invasive procedures defined as follows; major surgical procedures, open biopsy, or significant traumatic injury within 28 days prior to randomization, anticipation of need for major surgical procedure during the course of study, core biopsy or other minor procedure within 7 days prior to registration. * Following cardiac condition; New York Heart Association (NYHA) Class III or IV, myocardial infarction (MI) within 6 months, unstable angina within 6 months and current symptomatic arrhythmia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) | baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progressive Disease | randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) | Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. |
| Progression-Free Survival | randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) | Defined as the time from randomization to the first observation of disease progression, or death due to any cause. |
| Overall Survival | randomization to the date of death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) | Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. |
| Duration of Response | date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response - Avastin Subgroup | baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. |
| Duration of Response - A+FOLFOX4 - Avastin Subgroup | date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. |
| Time to Progressive Disease - Avastin Subgroup | randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) | Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. |
| Progression-Free Survival - Avastin Subgroup | randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) | Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. |
| Survival at 12 Months and 24 Months - Avastin Subgroup | randomization to the date of death from any cause (up to 24 months) | Percentage of participants who were alive at 12 months and 24 months. |
| Toxicity - Avastin Subgroup | every cycle (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) | Includes all Grade 3-4 hematologic toxicities and all non-hematologic toxicities with either \>=1 Grade 4 or \>=2 Grade 3 adverse events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A+FFG Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid) | 42 |
| A + FOLFOX 4 Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid) | 42 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Disease Progression | 23 | 6 |
| Overall Study | Lack of Efficacy | 0 | 0 |
| Overall Study | Other | 5 | 2 |
| Overall Study | Patient Non-Compliance | 0 | 1 |
| Overall Study | Physician Decision | 3 | 0 |
| Overall Study | Unacceptable Toxicity Exhibited by Drug | 2 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 5 |
Baseline characteristics
| Characteristic | A+FFG | Total | A + FOLFOX 4 |
|---|---|---|---|
| Age Continuous | 62 years | 63 years | 64 years |
| Diagnosis to Enrollment <6 months | 29 participants | 58 participants | 29 participants |
| Diagnosis to Enrollment >=6 months | 13 participants | 26 participants | 13 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - Fully Active | 23 participants | 43 participants | 20 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 - Ambulatory, Restricted Strenuous Activity | 19 participants | 41 participants | 22 participants |
| Primary Tumor Site Colon | 25 participants | 60 participants | 35 participants |
| Primary Tumor Site Other | 7 participants | 10 participants | 3 participants |
| Primary Tumor Site Rectum | 10 participants | 14 participants | 4 participants |
| Prior Adjuvant Therapy No | 30 participants | 58 participants | 28 participants |
| Prior Adjuvant Therapy Yes | 12 participants | 26 participants | 14 participants |
| Race/Ethnicity African descent | 5 participants | 11 participants | 6 participants |
| Race/Ethnicity Asian | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity Caucasian | 33 participants | 67 participants | 34 participants |
| Race/Ethnicity Hispanic | 4 participants | 5 participants | 1 participants |
| Region of Enrollment United States | 42 participants | 84 participants | 42 participants |
| Sex: Female, Male Female | 21 Participants | 43 Participants | 22 Participants |
| Sex: Female, Male Male | 21 Participants | 41 Participants | 20 Participants |
| Site of Metastasis Abdominal | 3 participants | 6 participants | 3 participants |
| Site of Metastasis Distant lymph nodes | 4 participants | 7 participants | 3 participants |
| Site of Metastasis Genitourinary | 1 participants | 1 participants | 0 participants |
| Site of Metastasis Liver | 28 participants | 57 participants | 29 participants |
| Site of Metastasis Lung | 13 participants | 24 participants | 11 participants |
| Site of Metastasis Other | 8 participants | 11 participants | 3 participants |
| Site of Metastasis Regional lymph nodes | 14 participants | 28 participants | 14 participants |
| Tumor Stage Distant metastasis | 25 participants | 45 participants | 20 participants |
| Tumor Stage Primary tumor | 37 participants | 78 participants | 41 participants |
| Tumor Stage Regional lymph nodes | 24 participants | 53 participants | 29 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 40 / 42 | 41 / 42 |
| serious Total, serious adverse events | 11 / 42 | 8 / 42 |
Outcome results
Primary
Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Time frame: baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Population: Intent-to-Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A+FFG | Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) | Complete Response (CR) | 1 participants |
| A+FFG | Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) | Disease Control Rate (CR+PR+SD) | 25 participants |
| A+FFG | Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) | Stable Disease (SD) | 21 participants |
| A+FFG | Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) | Progressive Disease | 14 participants |
| A+FFG | Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) | Partial Response (PR) | 3 participants |
| A+FFG | Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) | Unknown | 3 participants |
| A+FFG | Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) | Overall Response Rate (CR+PR) | 4 participants |
| A + FOLFOX 4 | Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) | Unknown | 2 participants |
| A + FOLFOX 4 | Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) | Overall Response Rate (CR+PR) | 17 participants |
| A + FOLFOX 4 | Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) | Complete Response (CR) | 2 participants |
| A + FOLFOX 4 | Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) | Stable Disease (SD) | 16 participants |
| A + FOLFOX 4 | Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) | Disease Control Rate (CR+PR+SD) | 33 participants |
| A + FOLFOX 4 | Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) | Progressive Disease | 7 participants |
| A + FOLFOX 4 | Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) | Partial Response (PR) | 15 participants |
Secondary
Duration of Response
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Time frame: date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Population: Intent to treat population who were responders (had best overall response of either complete response or partial response). Zero patients in A+FFG and 2 patients in A+FOLFOX4 were censored.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A+FFG | Duration of Response | 12.7 months |
| A + FOLFOX 4 | Duration of Response | 7.9 months |
Secondary
Overall Survival
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Time frame: randomization to the date of death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Population: Intent to treat population. Eight patients in A+FFG and 12 patients in A+FOLFOX4 were censored.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A+FFG | Overall Survival | 20.6 months |
| A + FOLFOX 4 | Overall Survival | 19.7 months |
Secondary
Progression-Free Survival
Defined as the time from randomization to the first observation of disease progression, or death due to any cause.
Time frame: randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Population: Intent to treat population. Three patients in A+FFG and 4 patients in A+FOLFOX4 were censored.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A+FFG | Progression-Free Survival | 8.6 months |
| A + FOLFOX 4 | Progression-Free Survival | 9.5 months |
Secondary
Time to Progressive Disease
Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
Time frame: randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Population: Intent to treat population. Five patients in A+FFG and 5 patients in A+FOLFOX4 were censored.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A+FFG | Time to Progressive Disease | 8.6 months |
| A + FOLFOX 4 | Time to Progressive Disease | 9.7 months |
Other Pre-specified
Duration of Response - A+FOLFOX4 - Avastin Subgroup
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Time frame: date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Population: The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Results were not calculable for the A+FFG-Avastin subgroup. Two patients were censored in the A+FOLFOX4-Avastin subgroup.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A+FFG | Duration of Response - A+FOLFOX4 - Avastin Subgroup | 5.2 months |
Other Pre-specified
Progression-Free Survival - Avastin Subgroup
Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
Time frame: randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Population: The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Three patients in A+FFG - Avastin subgroup and 3 patients in A+FOLFOX4 - Avastin subgroup were censored.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A+FFG | Progression-Free Survival - Avastin Subgroup | 13.7 months |
| A + FOLFOX 4 | Progression-Free Survival - Avastin Subgroup | 11.5 months |
Other Pre-specified
Survival at 12 Months and 24 Months - Avastin Subgroup
Percentage of participants who were alive at 12 months and 24 months.
Time frame: randomization to the date of death from any cause (up to 24 months)
Population: The original treatment regimens were FFG (Arm A) and FOLFOX (Arm B). Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A+FFG | Survival at 12 Months and 24 Months - Avastin Subgroup | 12-Month Survival | 75.6 percentage of participants alive |
| A+FFG | Survival at 12 Months and 24 Months - Avastin Subgroup | 24-Month Survival | 50.4 percentage of participants alive |
| A + FOLFOX 4 | Survival at 12 Months and 24 Months - Avastin Subgroup | 12-Month Survival | 83.3 percentage of participants alive |
| A + FOLFOX 4 | Survival at 12 Months and 24 Months - Avastin Subgroup | 24-Month Survival | 66.7 percentage of participants alive |
Other Pre-specified
Time to Progressive Disease - Avastin Subgroup
Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
Time frame: randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Population: The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Three patients in A+FFG - Avastin subgroup and 4 patients in A+FOLFOX4 - Avastin subgroup were censored.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A+FFG | Time to Progressive Disease - Avastin Subgroup | 13.7 months |
| A + FOLFOX 4 | Time to Progressive Disease - Avastin Subgroup | 13.8 months |
Other Pre-specified
Toxicity - Avastin Subgroup
Includes all Grade 3-4 hematologic toxicities and all non-hematologic toxicities with either \>=1 Grade 4 or \>=2 Grade 3 adverse events
Time frame: every cycle (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Population: The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A+FFG | Toxicity - Avastin Subgroup | Diarrhea (Grade 3) | 1 participants |
| A+FFG | Toxicity - Avastin Subgroup | Anemia (Grade 3) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Hyperglycemia (Grade 3) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Anemia (Grade 4) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Hyperglycemia (Grade 4) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Leukopenia (Grade 4) | 1 participants |
| A+FFG | Toxicity - Avastin Subgroup | Small intestinal obstruction (Grade 3) | 1 participants |
| A+FFG | Toxicity - Avastin Subgroup | Dehydration (Grade 3) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Small intestinal obstruction (Grade 4) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Diarrhea (Grade 4) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Fatigue (Grade 3) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Subdural hematoma (Grade 3) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Fatigue (Grade 4) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Febrile neutropenia (Grade 3) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Dehydration (Grade 4) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Subdural hematoma (Grade 4) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Deep vein thrombosis (Grade 3) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Neutropenia (Grade 3) | 3 participants |
| A+FFG | Toxicity - Avastin Subgroup | Deep vein thrombosis (Grade 4) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Leukopenia (Grade 3) | 3 participants |
| A+FFG | Toxicity - Avastin Subgroup | Myocardial infarction (Grade 3) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Neutropenia (Grade 4) | 5 participants |
| A+FFG | Toxicity - Avastin Subgroup | Myocardial infarction (Grade 4) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Cerebral infarction (Grade 3) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Perirectal abscess (Grade 3) | 1 participants |
| A+FFG | Toxicity - Avastin Subgroup | Thrombocytopenia (Grade 3) | 1 participants |
| A+FFG | Toxicity - Avastin Subgroup | Perirectal abscess (Grade 4) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Febrile neutropenia (Grade 4) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Hypoxia (Grade 3) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Thrombocytopenia (Grade 4) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Hypoxia (Grade 4) | 0 participants |
| A+FFG | Toxicity - Avastin Subgroup | Cerebral infarction (Grade 4) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Hypoxia (Grade 4) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Leukopenia (Grade 3) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Febrile neutropenia (Grade 3) | 1 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Diarrhea (Grade 3) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Diarrhea (Grade 4) | 1 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Fatigue (Grade 4) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Cerebral infarction (Grade 3) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Cerebral infarction (Grade 4) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Hyperglycemia (Grade 4) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Dehydration (Grade 3) | 1 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Subdural hematoma (Grade 3) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Neutropenia (Grade 3) | 5 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Neutropenia (Grade 4) | 1 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Thrombocytopenia (Grade 3) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Thrombocytopenia (Grade 4) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Leukopenia (Grade 4) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Anemia (Grade 3) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Anemia (Grade 4) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Febrile neutropenia (Grade 4) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Small intestinal obstruction (Grade 3) | 1 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Small intestinal obstruction (Grade 4) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Fatigue (Grade 3) | 2 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Hyperglycemia (Grade 3) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Dehydration (Grade 4) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Deep vein thrombosis (Grade 3) | 2 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Deep vein thrombosis (Grade 4) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Myocardial infarction (Grade 3) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Myocardial infarction (Grade 4) | 2 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Perirectal abscess (Grade 3) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Perirectal abscess (Grade 4) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Hypoxia (Grade 3) | 0 participants |
| A + FOLFOX 4 | Toxicity - Avastin Subgroup | Subdural hematoma (Grade 4) | 0 participants |
Other Pre-specified
Tumor Response - Avastin Subgroup
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Time frame: baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Population: The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A+FFG | Tumor Response - Avastin Subgroup | Complete Response (CR) | 0 participants |
| A+FFG | Tumor Response - Avastin Subgroup | Overall Response Rate (CR+PR) | 0 participants |
| A+FFG | Tumor Response - Avastin Subgroup | Progressive Disease | 6 participants |
| A+FFG | Tumor Response - Avastin Subgroup | Unknown | 1 participants |
| A+FFG | Tumor Response - Avastin Subgroup | Partial Response (PR) | 0 participants |
| A+FFG | Tumor Response - Avastin Subgroup | Stable Disease (SD) | 11 participants |
| A+FFG | Tumor Response - Avastin Subgroup | Disease Control Rate (CR+PR+SD) | 11 participants |
| A + FOLFOX 4 | Tumor Response - Avastin Subgroup | Disease Control Rate (CR+PR+SD) | 17 participants |
| A + FOLFOX 4 | Tumor Response - Avastin Subgroup | Complete Response (CR) | 1 participants |
| A + FOLFOX 4 | Tumor Response - Avastin Subgroup | Partial Response (PR) | 8 participants |
| A + FOLFOX 4 | Tumor Response - Avastin Subgroup | Unknown | 0 participants |
| A + FOLFOX 4 | Tumor Response - Avastin Subgroup | Overall Response Rate (CR+PR) | 9 participants |
| A + FOLFOX 4 | Tumor Response - Avastin Subgroup | Stable Disease (SD) | 8 participants |
| A + FOLFOX 4 | Tumor Response - Avastin Subgroup | Progressive Disease | 1 participants |