Trial Outcomes & Findings for S0213 Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma (NCT NCT00041132)

Last Updated: 2012-11-01

Results Overview

Progression-Free Survival (PFS) rate at 1 year. PFS measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is a 50% increase in the sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed if a complete response (confirmed, or unconfirmed) was not previously achieved; appearance of a new lesion/site; unequivocal progression of non-measurable disease; or death due to disease without prior documentation of progression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

56 participants

Primary outcome timeframe

assessed after cycle 4, after completion of treatment, then every 3 months until 1 year after registration

Results posted on

2012-11-01

Participant Flow

Participant milestones

Participant milestones
Measure	Hyper-CVAD + MTX/Ara-C + Rituximab 21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6. Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m\^2 on day 1, mesna 600 mg/m\^2 on days 2-4, cyclophosphamide 300 mg/m\^2 on days 2-4, doxorubicin 16.6 mg/m\^2/day on days 5-7, vincristine 1.4 mg/m\^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21. Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m\^2 on day 1, methotrexate 1000 mg/m\^2 over days 2-3, Ara-C 12 g/m\^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21.
Overall Study STARTED	56
Overall Study Eligible	49
Overall Study Eligible and Began Protocol Therapy	49
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Hyper-CVAD + MTX/Ara-C + Rituximab 21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6. Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m\^2 on day 1, mesna 600 mg/m\^2 on days 2-4, cyclophosphamide 300 mg/m\^2 on days 2-4, doxorubicin 16.6 mg/m\^2/day on days 5-7, vincristine 1.4 mg/m\^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21. Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m\^2 on day 1, methotrexate 1000 mg/m\^2 over days 2-3, Ara-C 12 g/m\^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21.
Overall Study Adverse Event	19
Overall Study Death	1
Overall Study Not Eligible	7
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	2

Baseline Characteristics

S0213 Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hyper-CVAD + MTX/Ara-C + Rituximab n=49 Participants 21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6. Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m\^2 on day 1, mesna 600 mg/m\^2 on days 2-4, cyclophosphamide 300 mg/m\^2 on days 2-4, doxorubicin 16.6 mg/m\^2/day on days 5-7, vincristine 1.4 mg/m\^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21. Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m\^2 on day 1, methotrexate 1000 mg/m\^2 over days 2-3, Ara-C 12 g/m\^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21.
Age Continuous	57.4 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: assessed after cycle 4, after completion of treatment, then every 3 months until 1 year after registration

Outcome measures

Outcome measures
Measure	Hyper-CVAD + MTX/Ara-C + Rituximab n=49 Participants 21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6. Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m\^2 on day 1, mesna 600 mg/m\^2 on days 2-4, cyclophosphamide 300 mg/m\^2 on days 2-4, doxorubicin 16.6 mg/m\^2/day on days 5-7, vincristine 1.4 mg/m\^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21. Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m\^2 on day 1, methotrexate 1000 mg/m\^2 over days 2-3, Ara-C 12 g/m\^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21.
Progression-free Survival	90 percentage of participants Interval 77.0 to 96.0

SECONDARY outcome

Timeframe: assessed after cycle 4 and after completion of treatment (168 days)

Complete (CR), complete unconfirmed (CRU) and partial responses (PR). CR is complete disappearance of all measurable and non-measurable disease with the exception of nodes; no new lesions; previously enlarged organs must have regressed in size; and if bone marrow positive at baseline, it must be negative. CRU is complete disappearance of all measurable and non-measurable disease; regressed, non-palpable organs; and one or more exceptions not qualifying for CR (see protocol section 10). PR applies to patients with at least one measurable lesion who do not qualify for CR or CRU. PR is a 50% decrease in sum of products of greatest diameters (SPD) for up to six identified dominant lesions identified at baseline; no new lesions; no increase in the size of liver, spleen or other nodes; and splenic and hepatic nodules must have regressed in size by at least 50% in SPD.

Outcome measures

Outcome measures
Measure	Hyper-CVAD + MTX/Ara-C + Rituximab n=49 Participants 21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6. Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m\^2 on day 1, mesna 600 mg/m\^2 on days 2-4, cyclophosphamide 300 mg/m\^2 on days 2-4, doxorubicin 16.6 mg/m\^2/day on days 5-7, vincristine 1.4 mg/m\^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21. Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m\^2 on day 1, methotrexate 1000 mg/m\^2 over days 2-3, Ara-C 12 g/m\^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21.
Response	42 participants

SECONDARY outcome

Timeframe: assessed after cycle 4, after completion of treatment, then every 3 months for 2 years, then every 6 months thereafter until 5 years

Overall Survival rate at 1 year. Time to death is from date of registration to date of death due to any cause.

Outcome measures

Outcome measures
Measure	Hyper-CVAD + MTX/Ara-C + Rituximab n=49 Participants 21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6. Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m\^2 on day 1, mesna 600 mg/m\^2 on days 2-4, cyclophosphamide 300 mg/m\^2 on days 2-4, doxorubicin 16.6 mg/m\^2/day on days 5-7, vincristine 1.4 mg/m\^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21. Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m\^2 on day 1, methotrexate 1000 mg/m\^2 over days 2-3, Ara-C 12 g/m\^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21.
Overall Survival	92 percentage of participants Interval 79.0 to 97.0

Adverse Events

Hyper-CVAD + MTX/Ara-C + Rituximab

Serious events: 4 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Hyper-CVAD + MTX/Ara-C + Rituximab n=49 participants at risk
Gastrointestinal disorders Colitis	2.0% 1/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Infections and infestations Infection with 3-4 neutropenia	2.0% 1/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary	2.0% 1/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Nervous system disorders Ataxia (incoordination)	2.0% 1/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).

Other adverse events

Other adverse events
Measure	Hyper-CVAD + MTX/Ara-C + Rituximab n=49 participants at risk
Blood and lymphatic system disorders Anemia	91.8% 45/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Blood and lymphatic system disorders Febrile neutropenia	20.4% 10/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Blood and lymphatic system disorders PRBC transfusion	24.5% 12/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Blood and lymphatic system disorders Platelet transfusion	16.3% 8/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Cardiac disorders Sinus tachycardia	10.2% 5/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Eye disorders Blurred vision	8.2% 4/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Eye disorders Dry eye	6.1% 3/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Gastrointestinal disorders Abdominal pain/cramping	6.1% 3/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Gastrointestinal disorders Constipation/bowel obstruction	46.9% 23/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Gastrointestinal disorders Diarrhea without colostomy	34.7% 17/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Gastrointestinal disorders Dyspepsia/heartburn	8.2% 4/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Gastrointestinal disorders Esophagitis/dysphagia	8.2% 4/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Gastrointestinal disorders Nausea	40.8% 20/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Gastrointestinal disorders Stomatitis/pharyngitis	53.1% 26/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Gastrointestinal disorders Vomiting	30.6% 15/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
General disorders Edema	46.9% 23/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
General disorders Fatigue/malaise/lethargy	87.8% 43/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
General disorders Fever without neutropenia	40.8% 20/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
General disorders Hemorrhage w/ 3-4 thrombocyt	10.2% 5/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
General disorders Pain-other	6.1% 3/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
General disorders Rigors/chills	16.3% 8/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Immune system disorders Allergic reaction	10.2% 5/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Infections and infestations Infection w/o 3-4 neutropenia	30.6% 15/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Infections and infestations Infection with 3-4 neutropenia	30.6% 15/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Infections and infestations Respiratory infect w/ neutrop	6.1% 3/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Infections and infestations Respiratory infect w/o neutrop	8.2% 4/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Investigations Alkaline phosphatase increase	16.3% 8/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Investigations Bilirubin increase	14.3% 7/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Investigations Creatinine increase	12.2% 6/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Investigations Leukopenia	89.8% 44/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Investigations Lymphopenia	63.3% 31/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Investigations Neutropenia/granulocytopenia	91.8% 45/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Investigations SGOT (AST) increase	36.7% 18/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Investigations SGPT (ALT) increase	20.4% 10/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Investigations Thrombocytopenia	87.8% 43/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Metabolism and nutrition disorders Anorexia	18.4% 9/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Metabolism and nutrition disorders Hyperglycemia	44.9% 22/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Metabolism and nutrition disorders Hyperuricemia	10.2% 5/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Metabolism and nutrition disorders Hypoalbuminemia	24.5% 12/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Metabolism and nutrition disorders Hypocalcemia	26.5% 13/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Metabolism and nutrition disorders Hypoglycemia	10.2% 5/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Metabolism and nutrition disorders Hypokalemia	30.6% 15/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Metabolism and nutrition disorders Hypomagnesemia	10.2% 5/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Metabolism and nutrition disorders Hyponatremia	22.4% 11/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 7/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Musculoskeletal and connective tissue disorders Bone pain	18.4% 9/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Musculoskeletal and connective tissue disorders Muscle weakness (not neuro)	6.1% 3/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Musculoskeletal and connective tissue disorders Myalgia	20.4% 10/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Musculoskeletal and connective tissue disorders Myalgia/arthralgia, NOS	6.1% 3/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Nervous system disorders Ataxia (incoordination)	8.2% 4/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Nervous system disorders Dizziness/vertigo, NOS	14.3% 7/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Nervous system disorders Headache	34.7% 17/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Nervous system disorders Sensory neuropathy	53.1% 26/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Nervous system disorders Taste disturbance	6.1% 3/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Psychiatric disorders Anxiety/agitation	12.2% 6/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Psychiatric disorders Insomnia	14.3% 7/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Renal and urinary disorders Urinary frequency/urgency	6.1% 3/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	6.1% 3/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Respiratory, thoracic and mediastinal disorders Cough	14.3% 7/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Respiratory, thoracic and mediastinal disorders Dyspnea	16.3% 8/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Respiratory, thoracic and mediastinal disorders Epistaxis	16.3% 8/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Respiratory, thoracic and mediastinal disorders Hypoxia	6.1% 3/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Respiratory, thoracic and mediastinal disorders Pneumonitis/infiltrates	6.1% 3/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Skin and subcutaneous tissue disorders Alopecia	71.4% 35/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Skin and subcutaneous tissue disorders Dry skin	6.1% 3/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Skin and subcutaneous tissue disorders Petechiae/purpura	12.2% 6/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Skin and subcutaneous tissue disorders Rash/desquamation	32.7% 16/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Vascular disorders Hypotension	20.4% 10/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Vascular disorders Phlebitis	6.1% 3/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).
Vascular disorders Thrombosis/embolism	12.2% 6/49 • Every week while on protocol treatment (through 8 cycles or 168 days), and 3 months after removal from protocol treatment (at between 8 and 9 months after beginning treatment).

Additional Information

Study Statistician

SWOG Statistical Center

Phone: 206-667-4623

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place