Carboplatin Plus Docetaxel (Taxotere) in Anaplastic Prostate Cancer

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00514540
• Collaborator: (none)
• Enrollment: 121
• Locations: 2
• Arm: 1
• Duration (Months): 83
• Patients Per Site: 60.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The goal of this clinical research study is to learn about how effective 2 chemotherapy drugs carboplatin (Paraplatin) plus docetaxel (Taxotere) in the treatment of patients with anaplastic prostate cancer. Patients who continue to have advanced disease will be switched to etoposide (VePesid) plus cisplatin (Platinol-AQ) to study how effective this second line of chemotherapy is in the treatment of patients iwth anaplastic prostate cancer.

The side effects, characteristics of patients who respond, and overall survival will also be studied.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Docetaxel; Drug: Carboplatin; Drug: Etoposide; Drug: Cisplatin	Phase 2

Detailed Description

Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division.

Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die. It is believed to be weakly effective at killing blood vessels in cancer cells as well.

Etoposide is a drug that has been shown to interfere with the growth of cancer cells, which may cause them to eventually die.

Cisplatin has an atom at its center that contains platinum. The platinum is supposed to poison the cancer cells, which may cause them to eventually die.

If you are found to be eligible to take part in this study, you will receive carboplatin plus docetaxel by a vein or central line in a vein. You will receive carboplatin over about 30 minutes and docetaxel over about 60 minutes. You will receive this therapy combination on Day 1 of each cycle of therapy (every 3-4 weeks), depending on the recovery of your bone marrow. These 3-4 weeks are considered 1 cycle of therapy. This therapy combination will be given on an outpatient basis. If you experience any side effects, your dose of docetaxel plus carboplatin may be decreased.

You will be given dexamethasone, by a vein in your arm, by central line in a vein, or by mouth, before your therapy begins with docetaxel plus carboplatin. Dexamethasone will help decrease bone marrow inflammation. You will also be given a colony stimulating factor (when the doctor thinks it is needed) to help maintain your white blood cell count to help decrease any chance of infection. Colony stimulating factor will be given as a subcutaneous injection (under the skin), at the discretion of the treating physician, during therapy.

You will have about 2-3 tablespoons of blood drawn at the beginning of each cycle of therapy for routine blood tests and blood tests for cancer markers. You will be asked about any medications you are currently taking.

At the end of the first 2 cycles of therapy, you will have some or all of the scans (performed during the screening visit) repeated to evaluate your disease. If your disease is responding well to the therapy, you will continue on docetaxel plus carboplatin for 2 more cycles. In this case, you will continue receive the study combination until your doctor thinks you have received the most benefit. You will then be followed with some or all of the scans (performed during the screening visit) every 2 months unless your cancer progresses (gets worse) or until you begin on a new therapy after your treatment has ended on this study.

If you are already taking hormone therapy with an luteinizing hormone-releasing hormone (LHRH) agonist (such as Lupron or Zoladex) , you will continue taking these medications. If you are taking an anti-androgen drug (such as Casodex), you should stop taking it.

If your cancer is progressing after having had a maximal response, if your disease does not respond after 2 courses of therapy, or if you are not able to tolerate some side effects of docetaxel plus carboplatin, your chemotherapy will be switched to etoposide plus cisplatin. If this is the case, etoposide plus cisplatin will be given to you by a vein in your arm or central line in a vein. You will receive this therapy combination once a day (etoposide over 60 minutes and cisplatin over 2 hours) for the first 3 days during each cycle of therapy, and then therapy will be repeated every 3 to 4 weeks.

Therapy with etoposide plus cisplatin will be continued as long as your cancer responds well to this therapy and you are not experiencing any intolerable side effects. If you experience any side effects, your dose of etoposide plus cisplatin may be decreased. This treatment combination may be given on an inpatient basis.

You will be removed from this study if your disease gets worse or you experience any intolerable side effects.

If you come off this study because you completed therapy, your disease got worse, or you experienced intolerable side effects, you will have an end-of-study visit. During this visit, you will have blood drawn (about 3 tablespoons) for routine tests. You will have a complete physical exam, including measurement of your vital signs. You will also have your complete medical history recorded and you will be asked about any medications you are currently taking. You will have imaging scans to evaluate your disease (similar to those at screening) if they have not been done in the last 28 days.

Once you are no longer on this study, the research staff will periodically check up on you (about every 6 months). This update will consist of a phone call, an e-mail, or a review of your medical and/or other records. No clinic visits or additional diagnostic studies are required by the study. If contacted by phone, the call would only last a few minutes.

This is an investigational study. Carboplatin, docetaxel, etoposide, and cisplatin are all commercially available and approved by the FDA. Up to 120 patients will take part in this multicenter study. Up to 90 will be enrolled at MD Anderson.

Study Design

• Study Type: Interventional
• Actual Enrollment: 121 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Carboplatin Plus Docetaxel (Taxotere) in Patients With Anaplastic Prostate Carcinoma
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm

Intervention/Treatment

Experimental: First-Line/Second-Line Chemotherapy First-Line (CD) Chemotherapy: Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m^2 IV over 60 minutes, Day 1. Repeated every 3 weeks. Second-Line (EP) Chemotherapy: Etoposide 120 mg/m^2 daily for 3 days and Cisplatin 25 mg/m^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks.

Drug: Docetaxel; 75 mg/m^2 IV over 60 Minutes on Day 1 of 21 day cycle.; Other Names: Taxotere ; Drug: Carboplatin; AUC = 5 IV Over 30 Minutes On Day 1 of 21 day cycle.; Other Names: Paraplatin ; Drug: Etoposide; 120 mg/m^2 daily for 3 days of 21 day cycle.; Drug: Cisplatin; 25 mg/m^2 for 3 days of 21 day cycle.

Outcome Measures

Primary Outcome Measures

1. Median Time to Progression (TTP) [Baseline to evaluation at end of course 2 (up to 168 days) then every 2 months for disease progression. Follow up every 6 months and overall study period was six and half years.]

   TTP defined as time of registration on study till disease progression. Disease status evaluated at the end of course 1 (up to 84 days after day 1 of cycle 1) and at the end of course 2 (up to 168 days after day 1 of cycle 1).

2. Response Rate of Salvage Chemotherapy With Etoposide Plus Cisplatin Following Treatment With Docetaxel Plus Carboplatin. [Evaluated at the end of course 1 (up to 84 days after day 1 of cycle 1) and at the end of course 2 (up to 168 days after day 1 of cycle 1)]

   Response rate is the number of participants with response compared to total. Response defined as the absence of disease progression compared to the participant's baseline evaluation, and the time to a serious adverse event (SAE), defined as grade 3 or 4 neurotoxicity or death.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient must have androgen independent Stage IV prostate cancer, with anaplastic features as defined by at least one of the following: a) Histologic evidence of small cell(pure/mixed), locally advanced or metastatic; b) Any of the following at Dx: exclusive visceral mets, predominant lytic mets, bulky ( >/= 5 cm) lymphadenopathy, or bulky ( >/= 5 cm) high-grade (Gleason >/= 8) tumor mass in the prostate/pelvis c) Low prostate-specific antigen (PSA) at diagnosis (Dx) + high volume bone mets.

2. (#1 cont'd) d) Neuroendocrine markers in histology (+ Chromogranin A and/or Synaptophysin) or serum (abnl high serum Chromogranin A or Bombesin) at Dx or at progression plus any of the following: elevated serum lactate dehydrogenase (LDH), malignant HyperCa+, or elevated serum Carcinoembryonic Antigen (CEA) in the absence of other etiologies. e) Short interval (< 6 months) to androgen-independent progression following initiation of hormonal therapy with or without presence of neuroendocrine markers.

3. Patients with small cell carcinoma on histology are not required to have received prior androgen deprivation therapy (ADT). All other patients must have evidence of disease progression while on ADT or an unsatisfactory response to >/= 1 month of castration, as defined by lack of symptom control and/or serum tumor marker response of < 20% (confirmed by a second value drawn on a different day).

4. Zubrod performance status of </= 2.

5. Normal EKG or, if EKG is suggestive of cardiomyopathy, patient has a resting Left Ventricular Ejection Fraction (LEVF) >/= 50% within 4 months.

6. Patient has all of the following pretreatment laboratory data within 14 days before registration: • Absolute neutrophil count (ANC) >=1,500/mm^{3.(unless due to bone marrow infiltration by tumor, in which case ANC >/= 500/mm}3 are allowed). • Platelets

=100,000/mm^{3 (unless due to bone marrow infiltration by tumor, in which case platelets >/= 20,000/mm}3 are allowed)

1. (#7 cont'd) • Total bilirubin </= 2 mg/dl; if greater, conjugated bilirubin should be <= 1.0 mg/dL, • serum glutamate pyruvate transaminase (SGPT) (ALT) and/or serum glutamate oxaloacetate transaminase (SGOT) (AST) </= 4 times the upper limit of normal (ULN). • Creatinine clearance >/= 40 (either measured or calculated by Cockcroft formula) • Castrate levels of serum testosterone (</= 50ng/mL) if no small cell elements on histology. (If small cell, testosterone > 50ng/mL)

2. Patient has given voluntary written informed consent before performance of any study-related procedure not part of standard medical care.

Exclusion Criteria:

1. Immunotherapy or chemotherapy within four weeks (nitrosoureas within six weeks) of registration.

2. 2 or more prior chemotherapy regimens (ketoconazole, aminoglutethimide or dutasteride do not count as chemotherapy for this trial).

3. Prior Platinum, Etoposide, or Taxane-based therapy that was completed less than 6 months from registration.

4. Samarium-153 within four weeks of registration, or Strontium-89 within 12 weeks of registration. Patients who have received 2 or more doses of bone-seeking radioisotopes are not eligible.

5. Patient has not recovered from all serious toxic effects of previous chemotherapy, radiation or antibody therapy, or from previous major surgery.

6. Patients with symptomatic and untreated brain metastases or central nervous system disease will be excluded. Patients with untreated, asymptomatic brain metastasis (not requiring corticosteroid treatment for control of central nervous system (CNS) symptoms) may be eligible, at the discretion of the MDACC Principal Investigator. Patients with treated brain metastases are eligible.

7. Patient with significant atherosclerotic disease, as defined by: a) myocardial infarction within six months of enrollment. Current uncontrolled/unstable angina pectoris or electrocardiographic evidence of acute ischemia b) clinically significant ventricular arrhythmias c) symptomatic congestive heart failure (NYHA Class III)

8. Patient has >= Grade 2 peripheral neuropathy.

9. Patient has renal insufficiency with cranial cruciate ligament (CrCL) < 40 ml/min with non-correctable etiologies.

10. Patient has an uncontrolled intercurrent illness (e.g., active infection).

11. Patient has another serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the patient's ability to provide informed consent or with the completion of treatment according to this protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California-San Francisco	San Francisco	California	United States	94143
2	UT MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Ana M. Aparicio, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• MD Anderson Cancer Center website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT00514540
• Other Study ID Numbers: 2006-0097
• First Posted: Aug 10, 2007
• Last Update Posted: Sep 1, 2020
• Last Verified: Aug 1, 2020

• Keywords provided by M.D. Anderson Cancer Center: Prostate Cancer; Anaplastic Prostate Cancer; Carboplatin; Docetaxel; Taxotere; Paraplatin
• Additional relevant MeSH terms: Prostatic Neoplasms; Carboplatin; Docetaxel; Etoposide

Study Results

Participant Flow

Recruitment Details	All participants were enrolled between June 2006 and October 2010 at The University of Texas (UT) MD Anderson Cancer Center (MDACC).
Pre-assignment Detail	Of the 121 participants enrolled, seven were ineligible and excluded. Another participant was eligible but withdrew before treatment.

Arm/Group Title	Chemotherapy First-Line Chemo (CD) + Second-Line (EP)
Arm/Group Description	First-Line (CD) Chemotherapy: Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m^2 IV over 60 minutes, Day 1. Repeated every 3 weeks. Colony stimulating factors given prophylactically per National Comprehensive Cancer Network (NCCN) guidelines. Second-Line (EP) Chemotherapy: Etoposide 120 mg/m^2 daily for 3 days and Cisplatin 25 mg/m^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks.
Period Title: First-Line Chemo
STARTED	113
COMPLETED	105
NOT COMPLETED	8
Period Title: First-Line Chemo
STARTED	105
COMPLETED	74
NOT COMPLETED	31

Baseline Characteristics

Arm/Group Title	First-Line CD + Second-Line EP
Arm/Group Description	First-Line (CD) Chemotherapy: Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m^2 IV over 60 minutes, Day 1. Repeated every 3 weeks. Colony stimulating factors given prophylactically per National Comprehensive Cancer Network (NCCN) guidelines. Second-Line (EP) Chemotherapy: Etoposide 120 mg/m^2 daily for 3 days and Cisplatin 25 mg/m^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks.
Overall Participants	113
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	63 55.8%
>=65 years	50 44.2%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	64
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	113 100%
Region of Enrollment (participants) [Number]
United States	113 100%

Outcome Measures

1. Primary Outcome

Title	Median Time to Progression (TTP)
Description	TTP defined as time of registration on study till disease progression. Disease status evaluated at the end of course 1 (up to 84 days after day 1 of cycle 1) and at the end of course 2 (up to 168 days after day 1 of cycle 1).
Time Frame	Baseline to evaluation at end of course 2 (up to 168 days) then every 2 months for disease progression. Follow up every 6 months and overall study period was six and half years.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	First-Line: Carboplatin + Docetaxel	Second-Line: Etoposide + Cisplatin
Arm/Group Description	Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m^2 IV over 60 minutes, Day 1 repeated every 3 weeks.	Etoposide 120 mg/m^2 daily for 3 days and Cisplatin 25 mg/m^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks.
Measure Participants	113	74
Median (95% Confidence Interval) [months]	5.1	3.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	First-Line: Carboplatin + Docetaxel, Second-Line: Etoposide + Cisplatin
	Comments	Disease status evaluated at the end of course 1 & the end of course 2. Primary outcomes are response, defined as the absence of disease progression, and the time to a serious adverse event (SAE), defined as grade 3 or 4 neurotoxicity or death. Bayesian probability model & decision rules used to monitor patient outcomes.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	< 0.005
	Comments	Stoppage of trial early if 1) probability of response with the frontline treatment DC in the 1st 2 courses is unacceptably low compared to a target of 30% Pr(p1*p2 > .30|data) < 0.005, or 2) risk of a SAE is unacceptably high Pr(m > m* |data) < 0.001
	Method	Bayesian probability model
	Comments	Operating Characteristics of futility monitoring rule 1 & safety monitoring rule 2 applied simultaneously for frontline treatment DC in courses 1 & 2.

2. Primary Outcome

Title	Response Rate of Salvage Chemotherapy With Etoposide Plus Cisplatin Following Treatment With Docetaxel Plus Carboplatin.
Description	Response rate is the number of participants with response compared to total. Response defined as the absence of disease progression compared to the participant's baseline evaluation, and the time to a serious adverse event (SAE), defined as grade 3 or 4 neurotoxicity or death.
Time Frame	Evaluated at the end of course 1 (up to 84 days after day 1 of cycle 1) and at the end of course 2 (up to 168 days after day 1 of cycle 1)

Outcome Measure Data

Analysis Population Description

74 of the 105 participants received second-line EP on study; the remainder withdrew from the study at their physician's or their own request. 2 participants died after course 1 of EP.

Arm/Group Title	Second-Line: EP, Course 1	Second-Line: EP, Course 2
Arm/Group Description	Etoposide 120 mg/m^2 daily for 3 days and Cisplatin 25 mg/m^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks.	Etoposide 120 mg/m^2 daily for 3 days and Cisplatin 25 mg/m^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks.
Measure Participants	74	41
Number [participants]	43 38.1%	24 NaN

Adverse Events

Time Frame	One therapy course consists of two (2) cycles, each cycle is defined as 21 days. Safety stopping rule assessed at the end of one course Docetaxel + Carboplatin and at the end of one course Etoposide + Cisplatin. Toxicity data collected for all cycles.
Arm/Group Title	First-Line: Carboplatin + Docetaxel		Second Line: Etoposide + Cisplatin
Arm/Group Description	Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m2 IV over 60 minutes, Day 1 repeated every 3 weeks		Etoposide 120 mg/m2 daily for 3 days and Cisplatin 25 mg/m2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics), Repeated every 3 weeks.
All Cause Mortality
	First-Line: Carboplatin + Docetaxel		Second Line: Etoposide + Cisplatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/113 (2.7%)		1/74 (1.4%)
Serious Adverse Events
	First-Line: Carboplatin + Docetaxel		Second Line: Etoposide + Cisplatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/113 (15.9%)		10/74 (13.5%)
Blood and lymphatic system disorders
Edema: Limb	1/113 (0.9%)	1	0/74 (0%)	1
Platelets	0/113 (0%)	0	2/74 (2.7%)	3
Neutrophils/Granulocytes	1/113 (0.9%)	1	0/74 (0%)	0
Cardiac disorders
Atrial fibrillation	1/113 (0.9%)	1	0/74 (0%)	0
Hypotension	1/113 (0.9%)	1	0/74 (0%)	0
Vasovagal episode	0/113 (0%)	0	1/74 (1.4%)	1
Gastrointestinal disorders
Vomiting	3/113 (2.7%)	3	1/74 (1.4%)	1
Nausea	1/113 (0.9%)	1	0/74 (0%)	0
General disorders
Fatigue	2/113 (1.8%)	2	1/74 (1.4%)	1
Rigors/chills	1/113 (0.9%)	1	0/74 (0%)	0
Infections and infestations
Cellulitis	1/113 (0.9%)	1	2/74 (2.7%)	2
Lung pneumonia	2/113 (1.8%)	2	0/74 (0%)	0
Upper airway infection	1/113 (0.9%)	1	0/74 (0%)	0
Sepsis	0/113 (0%)	0	1/74 (1.4%)	1
Bladder infection	0/113 (0%)	0	1/74 (1.4%)	1
Febrile Neutropenia	1/113 (0.9%)	1	1/74 (1.4%)	1
Infection	1/113 (0.9%)	1	2/74 (2.7%)	2
Metabolism and nutrition disorders
Hyperbilirubin	1/113 (0.9%)	1	0/74 (0%)	1
Creatinine	1/113 (0.9%)	1	0/74 (0%)	1
Nervous system disorders
CNS cerebrovascular ischemia	1/113 (0.9%)	1	0/74 (0%)	1
Encephalopathy	0/113 (0%)		1/74 (1.4%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/113 (0.9%)	2	0/74 (0%)	2
Pneumonitis	1/113 (0.9%)	1	0/74 (0%)	0
Skin and subcutaneous tissue disorders
Rash	1/113 (0.9%)	2	0/74 (0%)	0
Vascular disorders
Disseminated Intravascular Coagulation	0/113 (0%)		1/74 (1.4%)
Phlebitis	0/113 (0%)	0	2/74 (2.7%)	2
Thrombosis/embolism	1/113 (0.9%)	1	2/74 (2.7%)	2
Hemorrhage	0/113 (0%)	0	1/74 (1.4%)	1
Other (Not Including Serious) Adverse Events
	First-Line: Carboplatin + Docetaxel		Second Line: Etoposide + Cisplatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	112/113 (99.1%)		58/74 (78.4%)
Blood and lymphatic system disorders
Neutrophils/Granulocytes	62/113 (54.9%)	129	22/74 (29.7%)	36
Hyperbilirubinemia	9/113 (8%)	15	3/74 (4.1%)	3
Edema	18/113 (15.9%)	34	12/74 (16.2%)	12
Neutrophils/Granulocytes	62/113 (54.9%)	129	22/74 (29.7%)	96
Platelets	53/113 (46.9%)	124	42/74 (56.8%)	124
Eye disorders
Watery Eye	26/113 (23%)	45	5/74 (6.8%)	9
Gastrointestinal disorders
Anorexia	8/113 (7.1%)	15	4/74 (5.4%)	4
Constipation	13/113 (11.5%)	15	4/74 (5.4%)	4
Nausea	75/113 (66.4%)	216	34/74 (45.9%)	64
Dysgeusia	6/113 (5.3%)	14	0/74 (0%)	0
Vomitting	33/113 (29.2%)	97	13/74 (17.6%)	24
Diarrhea	56/113 (49.6%)	139	29/74 (39.2%)	31
Mucositis	17/113 (15%)	34	9/74 (12.2%)	15
General disorders
Fatigue (Asthenia, Lethargy, Malaise)	99/113 (87.6%)	359	44/74 (59.5%)	125
Fever	11/113 (9.7%)	13	3/74 (4.1%)	3
Pain	17/113 (15%)	23	5/74 (6.8%)	6
Infections and infestations
Infection with normal ANC	7/113 (6.2%)	8	3/74 (4.1%)	4
Metabolism and nutrition disorders
Hypoalbuminemia	27/113 (23.9%)	45	17/74 (23%)	27
ALT elevated	15/113 (13.3%)	25	2/74 (2.7%)	3
AST elevated	28/113 (24.8%)	42	10/74 (13.5%)	10
Hypocalcemia	10/113 (8.8%)	36	15/74 (20.3%)	30
Creatinine	12/113 (10.6%)	17	13/74 (17.6%)	18
Hemoglobin	76/113 (67.3%)	211	47/74 (63.5%)	139
Hypomagnesemia	38/113 (33.6%)	67	35/74 (47.3%)	66
Hypophosphatemia	7/113 (6.2%)	11	5/74 (6.8%)	8
Hyperkalemia	21/113 (18.6%)	30	9/74 (12.2%)	13
Hyponatremia	26/113 (23%)	45	25/74 (33.8%)	42
Hyperuricemia	5/113 (4.4%)	5	5/74 (6.8%)	5
Nervous system disorders
Neuropathy: Sensory	45/113 (39.8%)	79	16/74 (21.6%)	23
Respiratory, thoracic and mediastinal disorders
Dyspnea	42/113 (37.2%)	68	21/74 (28.4%)	24
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia	15/113 (13.3%)	16	0/74 (0%)	0
Injection Site Reaction/Extravasation Changes	7/113 (6.2%)	9	1/74 (1.4%)	1
Nail Changes	18/113 (15.9%)	20	1/74 (1.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.