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Trial record 2 of 10 for:    "Cervical Adenocarcinoma" | "Topotecan"

Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00064077
Recruitment Status : Completed
First Posted : July 9, 2003
Results First Posted : August 28, 2018
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Squamous Cell Carcinoma
Recurrent Cervical Carcinoma
Stage IVB Cervical Cancer
Interventions Drug: Cisplatin
Drug: Gemcitabine Hydrochloride
Drug: Paclitaxel
Other: Quality-of-Life Assessment
Drug: Topotecan Hydrochloride
Drug: Vinorelbine Tartrate
Enrollment 513
Recruitment Details From May 2003 through April 2007, 513 patients were enrolled. Interim analysis recommended early closure for futility in January 2004.
Pre-assignment Details Until January 2004, the study consisted of only two arms. Interim analysis recommended early closure for futility. 41 patients were enrolled until that point. These 41 patients were excluded from analysis. Two more arms were added and the study re-opened with 4 arms. The 472 patients enrolled after 1/26/2004 were included in analysis.
Arm/Group Title Arm I (Paclitaxel, Cisplatin) Arm II (Vinorelbine, Cisplatin) Arm III (Gemcitabine, Cisplatin) Arm IV (Topotecan, Cisplatin)
Hide Arm/Group Description

Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.

Cisplatin: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Vinorelbine Tartrate: Given IV

Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.

Cisplatin: Given IV

Gemcitabine Hydrochloride

Quality-of-Life Assessment: Ancillary studies

Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Topotecan Hydrochloride: Given IV

Period Title: Overall Study
Started 118 117 119 118
Completed 103 [1] 108 [1] 112 [1] 111 [1]
Not Completed 15 9 7 7
Reason Not Completed
Improper prior treatment             1             0             0             0
Poor risk             2             0             1             1
Pathology             10             7             3             4
No surgery             0             0             1             0
No tumor             0             0             1             0
Other reasons             2             2             1             2
[1]
Evaluable (treatment)
Arm/Group Title Arm I (Paclitaxel, Cisplatin) Arm II (Vinorelbine, Cisplatin) Arm III (Gemcitabine, Cisplatin) Arm IV (Topotecan, Cisplatin) Total
Hide Arm/Group Description

Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.

Cisplatin: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Vinorelbine Tartrate: Given IV

Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.

Cisplatin: Given IV

Gemcitabine Hydrochloride

Quality-of-Life Assessment: Ancillary studies

Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Topotecan Hydrochloride: Given IV

Total of all reporting groups
Overall Number of Baseline Participants 103 108 112 111 434
Hide Baseline Analysis Population Description
Evaluable (treatment)
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 103 participants 108 participants 112 participants 111 participants 434 participants
50
(29 to 81)
49
(24 to 76)
45
(20 to 89)
48
(25 to 75)
48
(20 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 108 participants 112 participants 111 participants 434 participants
Female
103
 100.0%
108
 100.0%
112
 100.0%
111
 100.0%
434
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 108 participants 112 participants 111 participants 434 participants
Hispanic or Latino
16
  15.5%
10
   9.3%
20
  17.9%
19
  17.1%
65
  15.0%
Not Hispanic or Latino
75
  72.8%
90
  83.3%
86
  76.8%
78
  70.3%
329
  75.8%
Unknown or Not Reported
12
  11.7%
8
   7.4%
6
   5.4%
14
  12.6%
40
   9.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 108 participants 112 participants 111 participants 434 participants
American Indian or Alaska Native
2
   1.9%
1
   0.9%
1
   0.9%
1
   0.9%
5
   1.2%
Asian
4
   3.9%
6
   5.6%
3
   2.7%
4
   3.6%
17
   3.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
19
  18.4%
20
  18.5%
23
  20.5%
17
  15.3%
79
  18.2%
White
75
  72.8%
79
  73.1%
80
  71.4%
82
  73.9%
316
  72.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   2.9%
2
   1.9%
5
   4.5%
7
   6.3%
17
   3.9%
1.Primary Outcome
Title Duration of Overall Survival (OS)
Hide Description Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Time Frame Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable (treatment)
Arm/Group Title Arm I (Paclitaxel, Cisplatin) Arm II (Vinorelbine, Cisplatin) Arm III (Gemcitabine, Cisplatin) Arm IV (Topotecan, Cisplatin)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.

Cisplatin: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Vinorelbine Tartrate: Given IV

Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.

Cisplatin: Given IV

Gemcitabine Hydrochloride

Quality-of-Life Assessment: Ancillary studies

Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Topotecan Hydrochloride: Given IV

Overall Number of Participants Analyzed 103 108 112 111
Median (95% Confidence Interval)
Unit of Measure: months
12.87
(10.02 to 16.76)
9.99
(8.25 to 12.25)
10.28
(7.62 to 11.60)
10.25
(8.61 to 11.66)
2.Secondary Outcome
Title Frequency of Response Using RECIST Version 1.0
Hide Description RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above.
Time Frame Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable (treatment)
Arm/Group Title Arm I (Paclitaxel, Cisplatin) Arm II (Vinorelbine, Cisplatin) Arm III (Gemcitabine, Cisplatin) Arm IV (Topotecan, Cisplatin)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.

Cisplatin: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Vinorelbine Tartrate: Given IV

Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.

Cisplatin: Given IV

Gemcitabine Hydrochloride

Quality-of-Life Assessment: Ancillary studies

Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Topotecan Hydrochloride: Given IV

Overall Number of Participants Analyzed 103 108 112 111
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
3
   2.9%
8
   7.4%
1
   0.9%
2
   1.8%
Partial Response
27
  26.2%
20
  18.5%
24
  21.4%
24
  21.6%
Stable Disease
50
  48.5%
46
  42.6%
54
  48.2%
53
  47.7%
Progressive Disease/other
23
  22.3%
34
  31.5%
33
  29.5%
32
  28.8%
3.Secondary Outcome
Title Duration of Progression-free Survival (PFS)
Hide Description Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Time Frame Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable (treatment)
Arm/Group Title Arm I (Paclitaxel, Cisplatin) Arm II (Vinorelbine, Cisplatin) Arm III (Gemcitabine, Cisplatin) Arm IV (Topotecan, Cisplatin)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.

Cisplatin: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Vinorelbine Tartrate: Given IV

Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.

Cisplatin: Given IV

Gemcitabine Hydrochloride

Quality-of-Life Assessment: Ancillary studies

Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Topotecan Hydrochloride: Given IV

Overall Number of Participants Analyzed 103 108 112 111
Median (95% Confidence Interval)
Unit of Measure: months
5.82
(4.53 to 7.59)
3.98
(3.19 to 5.16)
4.70
(3.58 to 5.59)
4.57
(3.71 to 5.75)
4.Secondary Outcome
Title Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)
Hide Description The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL.
Time Frame Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who provided baseline and ≥ one follow-up assessments
Arm/Group Title Arm I (Paclitaxel, Cisplatin) Arm II (Vinorelbine, Cisplatin) Arm III (Gemcitabine, Cisplatin) Arm IV (Topotecan, Cisplatin)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.

Cisplatin: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Vinorelbine Tartrate: Given IV

Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.

Cisplatin: Given IV

Gemcitabine Hydrochloride

Quality-of-Life Assessment: Ancillary studies

Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Topotecan Hydrochloride: Given IV

Overall Number of Participants Analyzed 86 89 92 96
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 66.6  (17.6) 69.1  (18.6) 67.9  (19.5) 68.1  (19.2)
Pre-cycle 2 65.2  (17.6) 65.5  (15.8) 65.3  (18.2) 66.2  (16.3)
Pre-cycle 5 70.5  (16.5) 66.6  (17.4) 64.5  (16.5) 68.4  (15.5)
9 months post cycle 1 71.9  (16.6) 69.9  (18.8) 68.6  (19.5) 70.9  (17.9)
5.Secondary Outcome
Title Pain, Assessed by Brief Pain Inventory
Hide Description Single item from the Brief Pain Inventory (BPI) assessing "worst pain" in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score.
Time Frame Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who provided baseline and ≥ one follow-up assessments
Arm/Group Title Arm I (Paclitaxel, Cisplatin) Arm II (Vinorelbine, Cisplatin) Arm III (Gemcitabine, Cisplatin) Arm IV (Topotecan, Cisplatin)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.

Cisplatin: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Vinorelbine Tartrate: Given IV

Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.

Cisplatin: Given IV

Gemcitabine Hydrochloride

Quality-of-Life Assessment: Ancillary studies

Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Topotecan Hydrochloride: Given IV

Overall Number of Participants Analyzed 74 83 86 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 4.0  (2.8) 3.9  (3.2) 3.3  (3.0) 3.6  (3.3)
Pre-cycle 2 3.5  (2.9) 3.5  (2.8) 3.4  (3.0) 3.6  (3.1)
Pre-cycle 5 3.6  (3.1) 4.0  (2.7) 3.5  (3.0) 2.5  (3.0)
9 months post cycle 1 2.3  (3.0) 3.2  (2.9) 3.7  (3.0) 2.9  (2.7)
6.Secondary Outcome
Title Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).
Hide Description The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity.
Time Frame Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who provided baseline and ≥ one follow-up assessments
Arm/Group Title Arm I (Paclitaxel, Cisplatin) Arm II (Vinorelbine, Cisplatin) Arm III (Gemcitabine, Cisplatin) Arm IV (Topotecan, Cisplatin)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.

Cisplatin: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Vinorelbine Tartrate: Given IV

Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.

Cisplatin: Given IV

Gemcitabine Hydrochloride

Quality-of-Life Assessment: Ancillary studies

Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Topotecan Hydrochloride: Given IV

Overall Number of Participants Analyzed 84 89 91 96
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 14.4  (2.9) 13.5  (3.4) 14.2  (2.9) 14.1  (3.5)
Pre-cycle 2 14.1  (3.2) 13.3  (3.6) 13.7  (3.5) 14.2  (3.2)
Pre-cycle 5 13.1  (3.5) 13.1  (3.7) 14.1  (3.0) 14.4  (3.2)
9 months post cycle 1 11.1  (5.2) 11.4  (4.7) 12.3  (3.7) 13.1  (3.5)
Time Frame Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Paclitaxel, Cisplatin) Arm II (Vinorelbine, Cisplatin) Arm III (Gemcitabine, Cisplatin) Arm IV (Topotecan, Cisplatin)
Hide Arm/Group Description

Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.

Cisplatin: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Vinorelbine Tartrate: Given IV

Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.

Cisplatin: Given IV

Gemcitabine Hydrochloride

Quality-of-Life Assessment: Ancillary studies

Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

Cisplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Topotecan Hydrochloride: Given IV

All-Cause Mortality
Arm I (Paclitaxel, Cisplatin) Arm II (Vinorelbine, Cisplatin) Arm III (Gemcitabine, Cisplatin) Arm IV (Topotecan, Cisplatin)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Paclitaxel, Cisplatin) Arm II (Vinorelbine, Cisplatin) Arm III (Gemcitabine, Cisplatin) Arm IV (Topotecan, Cisplatin)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   42/103 (40.78%)   39/108 (36.11%)   38/112 (33.93%)   38/111 (34.23%) 
Blood and lymphatic system disorders         
Leukopenia * 1  0/103 (0.00%)  2/108 (1.85%)  1/112 (0.89%)  2/111 (1.80%) 
Anemia * 1  3/103 (2.91%)  1/108 (0.93%)  2/112 (1.79%)  3/111 (2.70%) 
Thrombocytopenia * 1  1/103 (0.97%)  0/108 (0.00%)  0/112 (0.00%)  0/111 (0.00%) 
Neutropenia * 1  3/103 (2.91%)  8/108 (7.41%)  2/112 (1.79%)  7/111 (6.31%) 
Transfusion Prbc's * 1  0/103 (0.00%)  1/108 (0.93%)  1/112 (0.89%)  0/111 (0.00%) 
Cardiac disorders         
Thrombosis Embolism * 1  5/103 (4.85%)  9/108 (8.33%)  5/112 (4.46%)  3/111 (2.70%) 
Ischemia/Cardiac Infarction * 1  0/103 (0.00%)  1/108 (0.93%)  0/112 (0.00%)  0/111 (0.00%) 
Sinus Tachycardia * 1  0/103 (0.00%)  1/108 (0.93%)  0/112 (0.00%)  1/111 (0.90%) 
Cardiac Left Ventricular Function * 1  0/103 (0.00%)  0/108 (0.00%)  0/112 (0.00%)  1/111 (0.90%) 
Hypotension * 1  1/103 (0.97%)  2/108 (1.85%)  1/112 (0.89%)  0/111 (0.00%) 
Other Cardiovascular * 1  0/103 (0.00%)  0/108 (0.00%)  0/112 (0.00%)  2/111 (1.80%) 
Gastrointestinal disorders         
Nausea * 1  2/103 (1.94%)  0/108 (0.00%)  1/112 (0.89%)  1/111 (0.90%) 
Vomiting * 1  4/103 (3.88%)  1/108 (0.93%)  0/112 (0.00%)  0/111 (0.00%) 
Diarrhea Without Colostomy * 1  0/103 (0.00%)  1/108 (0.93%)  0/112 (0.00%)  0/111 (0.00%) 
Constipation * 1  2/103 (1.94%)  0/108 (0.00%)  2/112 (1.79%)  0/111 (0.00%) 
Dehydration * 1  5/103 (4.85%)  2/108 (1.85%)  3/112 (2.68%)  1/111 (0.90%) 
Anorexia * 1  2/103 (1.94%)  0/108 (0.00%)  0/112 (0.00%)  1/111 (0.90%) 
Ileus * 1  1/103 (0.97%)  0/108 (0.00%)  0/112 (0.00%)  0/111 (0.00%) 
Fistula Rectal/Anal * 1  0/103 (0.00%)  1/108 (0.93%)  0/112 (0.00%)  0/111 (0.00%) 
Proctitis * 1  0/103 (0.00%)  0/108 (0.00%)  0/112 (0.00%)  1/111 (0.90%) 
Diarrhea With Colostomy * 1  1/103 (0.97%)  0/108 (0.00%)  0/112 (0.00%)  0/111 (0.00%) 
Fistula Intestinal * 1  1/103 (0.97%)  0/108 (0.00%)  0/112 (0.00%)  1/111 (0.90%) 
Gi Other * 1  0/103 (0.00%)  0/108 (0.00%)  0/112 (0.00%)  1/111 (0.90%) 
General disorders         
Fatigue * 1  0/103 (0.00%)  0/108 (0.00%)  1/112 (0.89%)  0/111 (0.00%) 
Fever(No Neutropenia) * 1  0/103 (0.00%)  2/108 (1.85%)  2/112 (1.79%)  0/111 (0.00%) 
Bone Pain * 1  0/103 (0.00%)  0/108 (0.00%)  1/112 (0.89%)  1/111 (0.90%) 
Abdominal Pain * 1  3/103 (2.91%)  2/108 (1.85%)  1/112 (0.89%)  3/111 (2.70%) 
Pain Rectal/Perirectal * 1  1/103 (0.97%)  0/108 (0.00%)  0/112 (0.00%)  0/111 (0.00%) 
Pain Other * 1  1/103 (0.97%)  2/108 (1.85%)  1/112 (0.89%)  1/111 (0.90%) 
Immune system disorders         
Allergic Reaction * 1  2/103 (1.94%)  0/108 (0.00%)  0/112 (0.00%)  0/111 (0.00%) 
Infections and infestations         
Febrile With Neutropenia * 1  6/103 (5.83%)  2/108 (1.85%)  2/112 (1.79%)  2/111 (1.80%) 
Infection Without Neutropenia * 1  7/103 (6.80%)  4/108 (3.70%)  4/112 (3.57%)  5/111 (4.50%) 
Infection With Grade 3/4 Neutropenia * 1  1/103 (0.97%)  2/108 (1.85%)  0/112 (0.00%)  3/111 (2.70%) 
Infection No Anc * 1  1/103 (0.97%)  0/108 (0.00%)  0/112 (0.00%)  1/111 (0.90%) 
Catheter-Related Infection * 1  0/103 (0.00%)  0/108 (0.00%)  1/112 (0.89%)  0/111 (0.00%) 
Infection Other * 1  0/103 (0.00%)  1/108 (0.93%)  0/112 (0.00%)  0/111 (0.00%) 
Other Infection * 1  0/103 (0.00%)  3/108 (2.78%)  0/112 (0.00%)  0/111 (0.00%) 
Metabolism and nutrition disorders         
Hypokalemia * 1  1/103 (0.97%)  0/108 (0.00%)  1/112 (0.89%)  1/111 (0.90%) 
Hyperglycemia * 1  0/103 (0.00%)  0/108 (0.00%)  1/112 (0.89%)  1/111 (0.90%) 
Acidosis * 1  0/103 (0.00%)  1/108 (0.93%)  0/112 (0.00%)  0/111 (0.00%) 
Hyponatremia * 1  1/103 (0.97%)  0/108 (0.00%)  0/112 (0.00%)  0/111 (0.00%) 
Metabolic Other * 1  0/103 (0.00%)  0/108 (0.00%)  1/112 (0.89%)  0/111 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle Weakness * 1  1/103 (0.97%)  0/108 (0.00%)  0/112 (0.00%)  0/111 (0.00%) 
Musculoskeletal Other * 1  0/103 (0.00%)  1/108 (0.93%)  0/112 (0.00%)  1/111 (0.90%) 
Nervous system disorders         
Ataxia(Incoordination) * 1  1/103 (0.97%)  0/108 (0.00%)  0/112 (0.00%)  0/111 (0.00%) 
Cns Cerebrovascular Ischemia * 1  1/103 (0.97%)  0/108 (0.00%)  0/112 (0.00%)  0/111 (0.00%) 
Speech Impairment * 1  0/103 (0.00%)  0/108 (0.00%)  1/112 (0.89%)  0/111 (0.00%) 
Renal and urinary disorders         
Creatinine * 1  1/103 (0.97%)  2/108 (1.85%)  2/112 (1.79%)  1/111 (0.90%) 
Renal Failure * 1  1/103 (0.97%)  2/108 (1.85%)  0/112 (0.00%)  0/111 (0.00%) 
Fistula * 1  0/103 (0.00%)  1/108 (0.93%)  0/112 (0.00%)  0/111 (0.00%) 
Ureteral Obstruction * 1  1/103 (0.97%)  2/108 (1.85%)  4/112 (3.57%)  4/111 (3.60%) 
Renal/Gu Other * 1  1/103 (0.97%)  0/108 (0.00%)  0/112 (0.00%)  0/111 (0.00%) 
Other Genitourinary/Renal * 1  0/103 (0.00%)  1/108 (0.93%)  0/112 (0.00%)  0/111 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnea * 1  0/103 (0.00%)  0/108 (0.00%)  0/112 (0.00%)  3/111 (2.70%) 
Pneumothorax * 1  1/103 (0.97%)  0/108 (0.00%)  0/112 (0.00%)  0/111 (0.00%) 
Pulmonary Other * 1  0/103 (0.00%)  0/108 (0.00%)  1/112 (0.89%)  0/111 (0.00%) 
Skin and subcutaneous tissue disorders         
Wound Infectious * 1  1/103 (0.97%)  0/108 (0.00%)  0/112 (0.00%)  0/111 (0.00%) 
Skin Other * 1  0/103 (0.00%)  0/108 (0.00%)  1/112 (0.89%)  0/111 (0.00%) 
Vascular disorders         
Prothrombin Time * 1  0/103 (0.00%)  0/108 (0.00%)  0/112 (0.00%)  1/111 (0.90%) 
Hemorrhage With Grade 3/4 Thrombocytopenia * 1  0/103 (0.00%)  0/108 (0.00%)  1/112 (0.89%)  0/111 (0.00%) 
Melena/Gi Bleeding * 1  1/103 (0.97%)  0/108 (0.00%)  1/112 (0.89%)  1/111 (0.90%) 
Vaginal Bleeding * 1  0/103 (0.00%)  1/108 (0.93%)  2/112 (1.79%)  3/111 (2.70%) 
Hemoptysis * 1  0/103 (0.00%)  0/108 (0.00%)  1/112 (0.89%)  0/111 (0.00%) 
Rectal Bleeding/Hematochezia * 1  0/103 (0.00%)  0/108 (0.00%)  1/112 (0.89%)  0/111 (0.00%) 
Other Hemorrhage * 1  0/103 (0.00%)  0/108 (0.00%)  1/112 (0.89%)  0/111 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Paclitaxel, Cisplatin) Arm II (Vinorelbine, Cisplatin) Arm III (Gemcitabine, Cisplatin) Arm IV (Topotecan, Cisplatin)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   101/103 (98.06%)   105/108 (97.22%)   109/112 (97.32%)   108/111 (97.30%) 
Blood and lymphatic system disorders         
Leukopenia * 1  92/103 (89.32%)  98/108 (90.74%)  90/112 (80.36%)  102/111 (91.89%) 
Anemia * 1  94/103 (91.26%)  100/108 (92.59%)  104/112 (92.86%)  106/111 (95.50%) 
Thrombocytopenia * 1  36/103 (34.95%)  32/108 (29.63%)  88/112 (78.57%)  87/111 (78.38%) 
Neutropenia * 1  92/103 (89.32%)  94/108 (87.04%)  76/112 (67.86%)  102/111 (91.89%) 
Otherhematologic * 1  38/103 (36.89%)  53/108 (49.07%)  57/112 (50.89%)  57/111 (51.35%) 
Lymphatics * 1  1/103 (0.97%)  3/108 (2.78%)  2/112 (1.79%)  5/111 (4.50%) 
Cardiac disorders         
Thrombosis Embolism * 1  5/103 (4.85%)  7/108 (6.48%)  2/112 (1.79%)  5/111 (4.50%) 
Sinus Bradycardia * 1  1/103 (0.97%)  0/108 (0.00%)  0/112 (0.00%)  0/111 (0.00%) 
Cardiac Left Ventricular Function * 1  1/103 (0.97%)  0/108 (0.00%)  1/112 (0.89%)  2/111 (1.80%) 
Other Cardiovascular * 1  22/103 (21.36%)  15/108 (13.89%)  11/112 (9.82%)  13/111 (11.71%) 
Ear and labyrinth disorders         
Inner Ear/Hearing * 1  10/103 (9.71%)  14/108 (12.96%)  17/112 (15.18%)  11/111 (9.91%) 
Other Hearing * 1  2/103 (1.94%)  1/108 (0.93%)  2/112 (1.79%)  2/111 (1.80%) 
Endocrine disorders         
Endocrine * 1  9/103 (8.74%)  4/108 (3.70%)  4/112 (3.57%)  5/111 (4.50%) 
Eye disorders         
Ocular * 1  6/103 (5.83%)  5/108 (4.63%)  4/112 (3.57%)  8/111 (7.21%) 
Gastrointestinal disorders         
Nausea * 1  62/103 (60.19%)  64/108 (59.26%)  59/112 (52.68%)  61/111 (54.95%) 
Vomiting * 1  59/103 (57.28%)  51/108 (47.22%)  57/112 (50.89%)  49/111 (44.14%) 
Stomatitis/Pharyngitis * 1  18/103 (17.48%)  10/108 (9.26%)  21/112 (18.75%)  13/111 (11.71%) 
Other Gastrointestinal * 1  65/103 (63.11%)  67/108 (62.04%)  75/112 (66.96%)  66/111 (59.46%) 
General disorders         
Fatigue * 1  74/103 (71.84%)  82/108 (75.93%)  90/112 (80.36%)  85/111 (76.58%) 
Other Constitutional * 1  17/103 (16.50%)  23/108 (21.30%)  27/112 (24.11%)  28/111 (25.23%) 
Myalgia * 1  19/103 (18.45%)  9/108 (8.33%)  13/112 (11.61%)  12/111 (10.81%) 
Other Pain * 1  33/103 (32.04%)  47/108 (43.52%)  40/112 (35.71%)  40/111 (36.04%) 
Hepatobiliary disorders         
Hepatic * 1  17/103 (16.50%)  13/108 (12.04%)  16/112 (14.29%)  20/111 (18.02%) 
Immune system disorders         
Allergic Reaction * 1  10/103 (9.71%)  6/108 (5.56%)  4/112 (3.57%)  9/111 (8.11%) 
Other Allergy * 1  1/103 (0.97%)  4/108 (3.70%)  3/112 (2.68%)  3/111 (2.70%) 
Infections and infestations         
Febrile With Neutropenia * 1  13/103 (12.62%)  15/108 (13.89%)  6/112 (5.36%)  11/111 (9.91%) 
Infection Without Neutropenia * 1  19/103 (18.45%)  12/108 (11.11%)  19/112 (16.96%)  9/111 (8.11%) 
Other Infection * 1  11/103 (10.68%)  12/108 (11.11%)  5/112 (4.46%)  13/111 (11.71%) 
Metabolism and nutrition disorders         
Metabolic * 1  50/103 (48.54%)  50/108 (46.30%)  49/112 (43.75%)  48/111 (43.24%) 
Musculoskeletal and connective tissue disorders         
Musculoskeletal * 1  6/103 (5.83%)  6/108 (5.56%)  9/112 (8.04%)  8/111 (7.21%) 
Nervous system disorders         
Neuropathy Sensor * 1  37/103 (35.92%)  33/108 (30.56%)  21/112 (18.75%)  23/111 (20.72%) 
Otherneurologic * 1  27/103 (26.21%)  30/108 (27.78%)  28/112 (25.00%)  22/111 (19.82%) 
Renal and urinary disorders         
Creatinine * 1  15/103 (14.56%)  18/108 (16.67%)  20/112 (17.86%)  16/111 (14.41%) 
Other Genitourinary/Renal * 1  10/103 (9.71%)  9/108 (8.33%)  6/112 (5.36%)  14/111 (12.61%) 
Reproductive system and breast disorders         
Sexual/Reproductive * 1  0/103 (0.00%)  0/108 (0.00%)  2/112 (1.79%)  2/111 (1.80%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary * 1  20/103 (19.42%)  16/108 (14.81%)  11/112 (9.82%)  17/111 (15.32%) 
Skin and subcutaneous tissue disorders         
Alopecia * 1  65/103 (63.11%)  26/108 (24.07%)  22/112 (19.64%)  48/111 (43.24%) 
Rash Desquamation * 1  5/103 (4.85%)  3/108 (2.78%)  7/112 (6.25%)  7/111 (6.31%) 
Other Dermatologic * 1  15/103 (14.56%)  14/108 (12.96%)  11/112 (9.82%)  7/111 (6.31%) 
Vascular disorders         
Coagulation * 1  0/103 (0.00%)  3/108 (2.78%)  1/112 (0.89%)  1/111 (0.90%) 
Hemorrhage * 1  6/103 (5.83%)  7/108 (6.48%)  10/112 (8.93%)  9/111 (8.11%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Results Point of Contact
Name/Title: Angela Kuras on behalf of Michael Sill and Helen Huang
Organization: NRG Oncology
Phone: 716-845-5702
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00064077     History of Changes
Other Study ID Numbers: GOG-0204
NCI-2012-02540 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000306463
GOG-0204 ( Other Identifier: Gynecologic Oncology Group )
GOG-0204 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2003
First Posted: July 9, 2003
Results First Submitted: July 31, 2018
Results First Posted: August 28, 2018
Last Update Posted: October 17, 2018