Trial Outcomes & Findings for S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma (NCT NCT00033540)

Last Updated: 2017-09-12

Results Overview

Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

57 participants

Primary outcome timeframe

Patients assessed at least every six weeks while on protocol treatment

Results posted on

2017-09-12

Participant Flow

Participant milestones

Participant milestones
Measure	Capecitabine + Gemcitabine Capecitabine 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
Overall Study STARTED	57
Overall Study Eligible	54
Overall Study Eligible and Began Protocol Therapy	52
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	57

Reasons for withdrawal

Reasons for withdrawal
Measure	Capecitabine + Gemcitabine Capecitabine 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
Overall Study Adverse Event	14
Overall Study Death	1
Overall Study Progression	26
Overall Study Withdrawal by Subject	6
Overall Study Other	5
Overall Study Ineligible	3
Overall Study Never received treatment	2

Baseline Characteristics

S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capecitabine + Gemcitabine n=52 Participants Capecitabine 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
Age, Continuous	58.8 years n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Patients assessed at least every six weeks while on protocol treatment

Population: All eligible patients who started treatment were included in assessing response estimates.

Outcome measures

Outcome measures
Measure	Capecitabine + Gemcitabine n=52 Participants Capecitabine 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
Response Confirmed Partial Response	7 participants
Response Unconfirmed Partial Response	6 participants
Response Stable Disease	12 participants
Response Progression	15 participants
Response Symptomatic Deterioration	3 participants
Response Early Death	1 participants
Response Inadequate Assessment	8 participants

SECONDARY outcome

Timeframe: All patients will be followed until death or three years after registration, whichever is first.

Population: All eligible patients who started treatment were included in assessing response estimates.

Measured from time of registration to death, or last contact date

Outcome measures

Outcome measures
Measure	Capecitabine + Gemcitabine n=52 Participants Capecitabine 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
Overall Survival	7 months Interval 5.0 to 8.0

SECONDARY outcome

Timeframe: Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment.

Population: Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.

Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. For each patient, worst grade of each event type is reported.

Outcome measures

Outcome measures
Measure	Capecitabine + Gemcitabine n=51 Participants Capecitabine 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug ALT, SGPT (serum glutamic pyruvic transaminase)	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug AST,SGOT (serum glutamic oxaloacetic transaminase)	5 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Albumin, serum-low (hypoalbuminemia)	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Alkaline phosphatase	5 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Anorexia	2 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Ascites (non-malignant)	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Bilirubin (hyperbilirubinemia)	4 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Constipation	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Creatinine	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Dehydration	3 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Diarrhea	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Dysphagia (difficulty swallowing)	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Fatigue (asthenia, lethargy, malaise)	8 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hemoglobin	6 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hemolysis	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hemorrhage, GI - Esophagus	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Infection w/Grade 3-4 neutrophils - Upper airway	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Infection with normal ANC or Grade 1-2 neutrophils	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Leukocytes (total WBC)	9 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Mucositis/stomatitis (clinical exam) - Oral cavity	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Mucositis/stomatitis (function/symp)-Oral cavity	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Muscle weakness (not due to neuropathy)	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Nausea	3 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Neutrophils/granulocytes (ANC/AGC)	16 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pain - Abdomen NOS	2 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pain - Joint	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pain - Muscle	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pain - Tumor pain	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Platelets	12 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Potassium, serum-low (hypokalemia)	2 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Rash: hand-foot skin reaction	4 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Supraventricular nodal arrhythmia	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Thrombosis/thrombus/embolism	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Vomiting	2 Participants

SECONDARY outcome

Timeframe: 1-20 months

Population: Patients with advanced disease accrued between September 2003 to April 2005

Only eligible patients who received treatment were evaluable for response and survival outcomes.

Outcome measures

Outcome measures
Measure	Capecitabine + Gemcitabine n=57 Participants Capecitabine 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
Accrual of Patients With This Disease Site Eligible	54 participants
Accrual of Patients With This Disease Site Eligible and Analyzable	52 participants

SECONDARY outcome

Timeframe: All patients will be followed until death or three years after registration, whichever is first.

Population: Eligible patients who received genotyping were included in this analysis.

To evaluate in a preliminary fashion relevant prognostic markers in gallbladder and cholangiocarcinoma which may have prognostic implications as predictors of survival. Overall survival measured from time of registration to death, or last contact date.

Outcome measures

Outcome measures
Measure	Capecitabine + Gemcitabine n=22 Participants Capecitabine 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
Median Survival Time for Participants With Relevant Biologic Markers TS 5' Low functional significance (N=16)	9 months Interval 4.0 to 12.0
Median Survival Time for Participants With Relevant Biologic Markers TS 3' +/+ (N=14)	7 months Interval 4.0 to 13.0
Median Survival Time for Participants With Relevant Biologic Markers TS 3' +/- (N=6)	7 months Interval 2.0 to 7.0
Median Survival Time for Participants With Relevant Biologic Markers TS 3' -/- (N=2)	9 months Interval 2.0 to insufficient number of participants
Median Survival Time for Participants With Relevant Biologic Markers TS 5' Intermediate functional significance (N=16)	7 months Interval 2.0 to 7.0
Median Survival Time for Participants With Relevant Biologic Markers MTHFR C677T - C/C (N=11)	6 months Interval 4.0 to 9.0
Median Survival Time for Participants With Relevant Biologic Markers MTHFR C677T - C/T (N=11)	7 months Interval 2.0 to 13.0
Median Survival Time for Participants With Relevant Biologic Markers MTHFR A1298C - A/A (N=11)	7 months Interval 4.0 to 12.0
Median Survival Time for Participants With Relevant Biologic Markers MTHFR A1298C - A/C (N=8)	4 months Interval 2.0 to 6.0
Median Survival Time for Participants With Relevant Biologic Markers MTHFR A1298C - C/C (N=3)	9 months Interval 5.0 to 9.0
Median Survival Time for Participants With Relevant Biologic Markers RRMI G/A - G/G (N=9)	7 months Interval 4.0 to 7.0
Median Survival Time for Participants With Relevant Biologic Markers RRMI G/A - G/A (N=10)	9 months Interval 2.0 to 12.0
Median Survival Time for Participants With Relevant Biologic Markers RRMI G/A - A/A (N=3)	5 months Interval 4.0 to 5.0
Median Survival Time for Participants With Relevant Biologic Markers CDA A79C - A/A (N=8)	4 months Interval 2.0 to 5.0
Median Survival Time for Participants With Relevant Biologic Markers CDA A79C - A/C (N=12)	7 months Interval 5.0 to 9.0
Median Survival Time for Participants With Relevant Biologic Markers CDA A79C - C/C (N=1)	NA months insufficient number of participants

Adverse Events

Gemcitabine and Capecitabine

Serious events: 7 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gemcitabine and Capecitabine n=51 participants at risk Capecitabine 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
General disorders Constitutional Symptoms-Other (Specify)	3.9% 2/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Hepatobiliary disorders Hepatobiliary/Pancreas-Biliary obstruction	2.0% 1/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Blood	2.0% 1/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Investigations Bilirubin (hyperbilirubinemia)	2.0% 1/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death - Disease progression NOS	5.9% 3/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.

Other adverse events

Other adverse events
Measure	Gemcitabine and Capecitabine n=51 participants at risk Capecitabine 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
Blood and lymphatic system disorders Hemoglobin	82.4% 42/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Eye disorders Ocular surface disease	5.9% 3/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Gastrointestinal disorders Ascites (non-malignant)	7.8% 4/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Gastrointestinal disorders Constipation	41.2% 21/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Gastrointestinal disorders Diarrhea	33.3% 17/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Gastrointestinal disorders Heartburn/dyspepsia	7.8% 4/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	21.6% 11/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Gastrointestinal disorders Mucositis/stomatitis (functional/symp) - Oral cav	11.8% 6/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Gastrointestinal disorders Nausea	62.7% 32/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Gastrointestinal disorders Pain - Abdomen NOS	35.3% 18/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Gastrointestinal disorders Vomiting	37.3% 19/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
General disorders Edema: limb	23.5% 12/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
General disorders Fatigue (asthenia, lethargy, malaise)	86.3% 44/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
General disorders Fever in absence of neutropenia, ANC lt1.0x10e9/L	29.4% 15/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
General disorders Injection site reaction/extravasation changes	5.9% 3/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
General disorders Pain-Other (Specify)	7.8% 4/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
General disorders Rigors/chills	19.6% 10/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Hepatobiliary disorders Liver dysfunction/failure (clinical)	13.7% 7/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Bladder	7.8% 4/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Skin	5.9% 3/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	23.5% 12/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Investigations AST, SGOT	76.5% 39/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Investigations Alkaline phosphatase	70.6% 36/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Investigations Bilirubin (hyperbilirubinemia)	25.5% 13/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Investigations Creatinine	5.9% 3/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Investigations GGT (gamma-glutamyl transpeptidase)	5.9% 3/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Investigations Leukocytes (total WBC)	56.9% 29/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Investigations Neutrophils/granulocytes (ANC/AGC)	58.8% 30/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Investigations Platelets	56.9% 29/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Investigations Weight loss	15.7% 8/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	25.5% 13/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Metabolism and nutrition disorders Anorexia	27.5% 14/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	13.7% 7/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Metabolism and nutrition disorders Dehydration	7.8% 4/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	35.3% 18/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	5.9% 3/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	9.8% 5/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	17.6% 9/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Musculoskeletal and connective tissue disorders Muscle weakness, not d/t neuropathy - Extrem-lower	5.9% 3/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Musculoskeletal and connective tissue disorders Muscle weakness, not d/t neuropathy - body/general	5.9% 3/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Musculoskeletal and connective tissue disorders Pain - Back	15.7% 8/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	5.9% 3/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Musculoskeletal and connective tissue disorders Pain - Joint	7.8% 4/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Musculoskeletal and connective tissue disorders Pain - Muscle	7.8% 4/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pain - Tumor pain	27.5% 14/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Nervous system disorders Neuropathy: sensory	9.8% 5/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Nervous system disorders Pain - Head/headache	13.7% 7/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Nervous system disorders Taste alteration (dysgeusia)	7.8% 4/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Psychiatric disorders Insomnia	9.8% 5/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Psychiatric disorders Mood alteration - anxiety	7.8% 4/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Psychiatric disorders Mood alteration - depression	5.9% 3/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Respiratory, thoracic and mediastinal disorders Cough	9.8% 5/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	25.5% 13/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	5.9% 3/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Skin and subcutaneous tissue disorders Dry skin	5.9% 3/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Skin and subcutaneous tissue disorders Hair loss/Alopecia (scalp or body)	23.5% 12/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Skin and subcutaneous tissue disorders Nail changes	11.8% 6/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Skin and subcutaneous tissue disorders Pruritus/itching	19.6% 10/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Skin and subcutaneous tissue disorders Rash/desquamation	27.5% 14/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	21.6% 11/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Vascular disorders Thrombosis/thrombus/embolism	5.9% 3/51 • Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment. One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.

Additional Information

Study Statistician

Southwest Oncology Group (SWOG) Statistical Center

Phone: 206-667-4623

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place