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Trial record 2 of 4 for:    "Hydatidiform Mole, Recurrent, 1" | "Folic Acid"

Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia

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: NCT01535053
Recruitment Status : Active, not recruiting
First Posted : February 17, 2012
Results First Posted : August 13, 2019
Last Update Posted : August 13, 2019
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 Choriocarcinoma
FIGO Stage I Gestational Trophoblastic Tumor
FIGO Stage II Gestational Trophoblastic Tumor
FIGO Stage III Gestational Trophoblastic Tumor
Hydatidiform Mole
Interventions Biological: Dactinomycin
Drug: Leucovorin Calcium
Drug: Methotrexate
Other: Quality-of-Life Assessment
Enrollment 57
Recruitment Details The study was activated on 6/18/2012and closed to accrual prematurely on 9/20/2016 by the sponsor due to slow accrual.
Pre-assignment Details Sites declared in advance which of 2 methotrexate regimens they would follow for patients who received a random treatment allocation to the methotrexate arm. Randomization is stratified by country (US, Canada, Japan, Korea, Australia, United Kingdom, etc.) and Multi-day methotrexate regimen (8- or 5-day) used by the participating site.
Arm/Group Title Regimen I (Dactinomycin) Regimen II (Methotrexate)
Hide Arm/Group Description IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)

institutional preference of either:

  • IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
  • IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
Period Title: Overall Study
Started 29 28
Completed 28 [1] 26 [1]
Not Completed 1 2
Reason Not Completed
Ineligible             1             2
[1]
treated for 3 cycles after hCG <5mIU/ml or until biologic,disease progression, unacceptable toxicity
Arm/Group Title Regimen I (Dactinomycin) Regimen II (Methotrexate) Total
Hide Arm/Group Description IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)

institutional preference of either:

  • IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
  • IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
Total of all reporting groups
Overall Number of Baseline Participants 28 26 54
Hide Baseline Analysis Population Description
Eligible and treated patients
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 26 participants 54 participants
10-19 years
1
   3.6%
1
   3.8%
2
   3.7%
20-29 years
14
  50.0%
11
  42.3%
25
  46.3%
30-39 years
11
  39.3%
11
  42.3%
22
  40.7%
40-49 years
2
   7.1%
3
  11.5%
5
   9.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 26 participants 54 participants
Female
28
 100.0%
26
 100.0%
54
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 26 participants 54 participants
Hispanic or Latino
26
  92.9%
24
  92.3%
50
  92.6%
Not Hispanic or Latino
2
   7.1%
2
   7.7%
4
   7.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 26 participants 54 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
6
  21.4%
6
  23.1%
12
  22.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  21.4%
1
   3.8%
7
  13.0%
White
16
  57.1%
19
  73.1%
35
  64.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Complete Response
Hide Description Complete Response is defined as 3 consecutive bi-weekly values of hCG<5 over a minimum of 4 weeks of normal hCG values with no values greater than 5 mIU/ml
Time Frame hCG testing is performed prior to each cycle to treatment until treatment is completed, up to 10 months. For patients who have responded to treatment hCG must be obtained every 4 weeks for 1 year after completing treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients
Arm/Group Title Regimen I (Dactinomycin) Regimen II (Methotrexate)
Hide Arm/Group Description:
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)

institutional preference of either:

  • IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
  • IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
Overall Number of Participants Analyzed 28 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
78.6
(59.0 to 91.7)
88.5
(69.8 to 97.6)
2.Secondary Outcome
Title Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm
Hide Description Maximum grade of physician assessed adverse events reported during treatment
Time Frame Assessed throughout the treatment period and within 2-4 weeks after discontinuation of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Regimen I (Dactinomycin) Regimen II (Methotrexate)
Hide Arm/Group Description:
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)

institutional preference of either:

  • IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
  • IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
Overall Number of Participants Analyzed 28 26
Measure Type: Number
Unit of Measure: participants
Grade 1 7 4
Grade 2 14 10
Grade 3 6 10
Grade 4 0 0
Grade 5 0 0
3.Secondary Outcome
Title The Number of Participants With Post Protocol Surgical Treatment for Each Arm.
Hide Description [Not Specified]
Time Frame Anytime during post treatment follow-up for up to 2 years from study entry.
Hide Outcome Measure Data
Hide Analysis Population Description
Non-responding eligible patients in follow-up
Arm/Group Title Regimen I (Dactinomycin) Regimen II (Methotrexate)
Hide Arm/Group Description:
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)

institutional preference of either:

  • IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
  • IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
Overall Number of Participants Analyzed 7 5
Measure Type: Number
Unit of Measure: participants
0 0
4.Secondary Outcome
Title The Number of Participants With Post Protocol Multi-agent Chemotherapy Treatment for Each Arm.
Hide Description [Not Specified]
Time Frame Anytime during post treatment follow-up for up to 2 years from study entry.
Hide Outcome Measure Data
Hide Analysis Population Description
Non-responding eligible patients in follow-up
Arm/Group Title Regimen I (Dactinomycin) Regimen II (Methotrexate)
Hide Arm/Group Description:
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)

institutional preference of either:

  • IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
  • IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
Overall Number of Participants Analyzed 7 5
Measure Type: Number
Unit of Measure: participants
0 0
5.Secondary Outcome
Title Patient-reported Quality of Life (QOL) at Baseline
Hide Description Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G 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, 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 FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL.
Time Frame Prior to cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Provided baseline QOL questionnaire
Arm/Group Title Regimen I (Dactinomycin) Regimen II (Methotrexate)
Hide Arm/Group Description:
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)

institutional preference of either:

  • IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
  • IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
Overall Number of Participants Analyzed 27 27
Mean (Standard Error)
Unit of Measure: units on a scale
82.3  (2.7) 81.9  (3.3)
6.Secondary Outcome
Title Patient-reported Quality of Life (QOL) After Baseline Visit.
Hide Description Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G 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, 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 FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL.
Time Frame Prior to cycle 3 (4 weeks after cycle 1 if off study treatment prior to cycle 3). Prior to cycle 5, Prior to cycle 7, 26 weeks after starting study treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Provided baseline and ≥1 follow-up assessments
Arm/Group Title Regimen I (Dactinomycin) Regimen II (Methotrexate)
Hide Arm/Group Description:
IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)

institutional preference of either:

  • IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
  • IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
Overall Number of Participants Analyzed 27 27
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Pre-cycle 3 78.3  (2.3) 81.6  (2.7)
Pre-cycle 5 75.5  (3.3) 78.9  (2.8)
Pre-cycle 7 85.0  (2.7) 84.5  (2.2)
26 weeks 91.2  (2.9) 90.9  (2.9)
Time Frame Through Study Treatment and up to 30 days after discontinuing treatment.
Adverse Event Reporting Description Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.
 
Arm/Group Title Regimen I (Dactinomycin) Regimen II (Methotrexate)
Hide Arm/Group Description IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)

institutional preference of either:

  • IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
  • IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.
All-Cause Mortality
Regimen I (Dactinomycin) Regimen II (Methotrexate)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/28 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Regimen I (Dactinomycin) Regimen II (Methotrexate)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/28 (3.57%)   1/26 (3.85%) 
Infections and infestations     
Appendicitis * 1  0/28 (0.00%)  1/26 (3.85%) 
Psychiatric disorders     
Psychiatric Disorders - Other * 1  1/28 (3.57%)  0/26 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Regimen I (Dactinomycin) Regimen II (Methotrexate)
Affected / at Risk (%) Affected / at Risk (%)
Total   27/28 (96.43%)   24/26 (92.31%) 
Blood and lymphatic system disorders     
Lymph Node Pain * 1  0/28 (0.00%)  1/26 (3.85%) 
Blood And Lymphatic System Disorders - Other * 1  1/28 (3.57%)  3/26 (11.54%) 
Anemia * 1  13/28 (46.43%)  15/26 (57.69%) 
Cardiac disorders     
Palpitations * 1  1/28 (3.57%)  1/26 (3.85%) 
Cardiac Disorders - Other * 1  0/28 (0.00%)  1/26 (3.85%) 
Ear and labyrinth disorders     
Tinnitus * 1  1/28 (3.57%)  4/26 (15.38%) 
Hearing Impaired * 1  0/28 (0.00%)  1/26 (3.85%) 
Ear Pain * 1  2/28 (7.14%)  0/26 (0.00%) 
Eye disorders     
Eye Disorders - Other * 1  0/28 (0.00%)  3/26 (11.54%) 
Watering Eyes * 1  0/28 (0.00%)  4/26 (15.38%) 
Eye Pain * 1  1/28 (3.57%)  0/26 (0.00%) 
Photophobia * 1  0/28 (0.00%)  1/26 (3.85%) 
Blurred Vision * 1  4/28 (14.29%)  3/26 (11.54%) 
Dry Eye * 1  0/28 (0.00%)  4/26 (15.38%) 
Gastrointestinal disorders     
Dysphagia * 1  1/28 (3.57%)  3/26 (11.54%) 
Dyspepsia * 1  0/28 (0.00%)  1/26 (3.85%) 
Constipation * 1  12/28 (42.86%)  11/26 (42.31%) 
Diarrhea * 1  7/28 (25.00%)  7/26 (26.92%) 
Vomiting * 1  8/28 (28.57%)  6/26 (23.08%) 
Stomach Pain * 1  0/28 (0.00%)  2/26 (7.69%) 
Abdominal Pain * 1  10/28 (35.71%)  6/26 (23.08%) 
Oral Dysesthesia * 1  1/28 (3.57%)  0/26 (0.00%) 
Mucositis Oral * 1  12/28 (42.86%)  20/26 (76.92%) 
Gastrointestinal Disorders - Other * 1  0/28 (0.00%)  1/26 (3.85%) 
Gingival Pain * 1  1/28 (3.57%)  1/26 (3.85%) 
Nausea * 1  20/28 (71.43%)  16/26 (61.54%) 
Gastroesophageal Reflux Disease * 1  3/28 (10.71%)  1/26 (3.85%) 
General disorders     
General Disorders And Administration Site Conditio * 1  3/28 (10.71%)  0/26 (0.00%) 
Pain * 1  0/28 (0.00%)  2/26 (7.69%) 
Malaise * 1  3/28 (10.71%)  1/26 (3.85%) 
Localized Edema * 1  0/28 (0.00%)  1/26 (3.85%) 
Flu Like Symptoms * 1  1/28 (3.57%)  2/26 (7.69%) 
Non-Cardiac Chest Pain * 1  1/28 (3.57%)  0/26 (0.00%) 
Edema Limbs * 1  1/28 (3.57%)  0/26 (0.00%) 
Edema Face * 1  0/28 (0.00%)  1/26 (3.85%) 
Fatigue * 1  18/28 (64.29%)  15/26 (57.69%) 
Fever * 1  2/28 (7.14%)  1/26 (3.85%) 
Chills * 1  1/28 (3.57%)  1/26 (3.85%) 
Immune system disorders     
Allergic Reaction * 1  0/28 (0.00%)  1/26 (3.85%) 
Infections and infestations     
Infections And Infestations - Other * 1  4/28 (14.29%)  1/26 (3.85%) 
Upper Respiratory Infection * 1  0/28 (0.00%)  1/26 (3.85%) 
Vulval Infection * 1  0/28 (0.00%)  1/26 (3.85%) 
Skin Infection * 1  1/28 (3.57%)  2/26 (7.69%) 
Pharyngitis * 1  0/28 (0.00%)  1/26 (3.85%) 
Vaginal Infection * 1  0/28 (0.00%)  2/26 (7.69%) 
Urinary Tract Infection * 1  1/28 (3.57%)  1/26 (3.85%) 
Injury, poisoning and procedural complications     
Bruising * 1  1/28 (3.57%)  0/26 (0.00%) 
Investigations     
Investigations - Other * 1  1/28 (3.57%)  0/26 (0.00%) 
Weight Gain * 1  0/28 (0.00%)  2/26 (7.69%) 
Platelet Count Decreased * 1  3/28 (10.71%)  4/26 (15.38%) 
Hemoglobin Increased * 1  1/28 (3.57%)  0/26 (0.00%) 
Ggt Increased * 1  1/28 (3.57%)  1/26 (3.85%) 
Neutrophil Count Decreased * 1  5/28 (17.86%)  7/26 (26.92%) 
White Blood Cell Decreased * 1  4/28 (14.29%)  6/26 (23.08%) 
Aspartate Aminotransferase Increased * 1  2/28 (7.14%)  1/26 (3.85%) 
Alkaline Phosphatase Increased * 1  1/28 (3.57%)  0/26 (0.00%) 
Alanine Aminotransferase Increased * 1  2/28 (7.14%)  1/26 (3.85%) 
Metabolism and nutrition disorders     
Hypophosphatemia * 1  0/28 (0.00%)  2/26 (7.69%) 
Hyponatremia * 1  1/28 (3.57%)  0/26 (0.00%) 
Hypokalemia * 1  2/28 (7.14%)  0/26 (0.00%) 
Hypoglycemia * 1  3/28 (10.71%)  0/26 (0.00%) 
Hypocalcemia * 1  1/28 (3.57%)  2/26 (7.69%) 
Hypoalbuminemia * 1  1/28 (3.57%)  2/26 (7.69%) 
Hyperglycemia * 1  4/28 (14.29%)  1/26 (3.85%) 
Anorexia * 1  4/28 (14.29%)  7/26 (26.92%) 
Musculoskeletal and connective tissue disorders     
Pain In Extremity * 1  1/28 (3.57%)  1/26 (3.85%) 
Myalgia * 1  3/28 (10.71%)  1/26 (3.85%) 
Generalized Muscle Weakness * 1  2/28 (7.14%)  0/26 (0.00%) 
Back Pain * 1  2/28 (7.14%)  1/26 (3.85%) 
Arthralgia * 1  1/28 (3.57%)  0/26 (0.00%) 
Musculoskeletal And Connective Tissue Disorder - O * 1  0/28 (0.00%)  1/26 (3.85%) 
Nervous system disorders     
Peripheral Sensory Neuropathy * 1  1/28 (3.57%)  0/26 (0.00%) 
Peripheral Motor Neuropathy * 1  1/28 (3.57%)  0/26 (0.00%) 
Paresthesia * 1  1/28 (3.57%)  1/26 (3.85%) 
Headache * 1  8/28 (28.57%)  5/26 (19.23%) 
Facial Muscle Weakness * 1  1/28 (3.57%)  0/26 (0.00%) 
Dysgeusia * 1  1/28 (3.57%)  0/26 (0.00%) 
Syncope * 1  1/28 (3.57%)  0/26 (0.00%) 
Dizziness * 1  2/28 (7.14%)  0/26 (0.00%) 
Psychiatric disorders     
Psychiatric Disorders - Other * 1  1/28 (3.57%)  0/26 (0.00%) 
Suicidal Ideation * 1  0/28 (0.00%)  1/26 (3.85%) 
Personality Change * 1  1/28 (3.57%)  0/26 (0.00%) 
Insomnia * 1  1/28 (3.57%)  6/26 (23.08%) 
Depression * 1  1/28 (3.57%)  1/26 (3.85%) 
Confusion * 1  0/28 (0.00%)  1/26 (3.85%) 
Anxiety * 1  2/28 (7.14%)  2/26 (7.69%) 
Renal and urinary disorders     
Urinary Retention * 1  1/28 (3.57%)  0/26 (0.00%) 
Urinary Tract Pain * 1  1/28 (3.57%)  0/26 (0.00%) 
Urinary Frequency * 1  1/28 (3.57%)  0/26 (0.00%) 
Proteinuria * 1  0/28 (0.00%)  1/26 (3.85%) 
Hematuria * 1  1/28 (3.57%)  3/26 (11.54%) 
Reproductive system and breast disorders     
Reproductive System And Breast Disorders - Other * 1  1/28 (3.57%)  0/26 (0.00%) 
Vaginal Hemorrhage * 1  6/28 (21.43%)  7/26 (26.92%) 
Vaginal Dryness * 1  0/28 (0.00%)  1/26 (3.85%) 
Perineal Pain * 1  1/28 (3.57%)  0/26 (0.00%) 
Pelvic Pain * 1  1/28 (3.57%)  1/26 (3.85%) 
Menorrhagia * 1  2/28 (7.14%)  0/26 (0.00%) 
Irregular Menstruation * 1  1/28 (3.57%)  0/26 (0.00%) 
Vaginal Discharge * 1  5/28 (17.86%)  3/26 (11.54%) 
Vaginal Inflammation * 1  0/28 (0.00%)  1/26 (3.85%) 
Respiratory, thoracic and mediastinal disorders     
Sore Throat * 1  1/28 (3.57%)  0/26 (0.00%) 
Sneezing * 1  1/28 (3.57%)  0/26 (0.00%) 
Pleuritic Pain * 1  0/28 (0.00%)  3/26 (11.54%) 
Dyspnea * 1  5/28 (17.86%)  4/26 (15.38%) 
Cough * 1  4/28 (14.29%)  2/26 (7.69%) 
Allergic Rhinitis * 1  1/28 (3.57%)  1/26 (3.85%) 
Skin and subcutaneous tissue disorders     
Skin And Subcutaneous Tissue Disorders - Other * 1  2/28 (7.14%)  2/26 (7.69%) 
Urticaria * 1  1/28 (3.57%)  0/26 (0.00%) 
Skin Ulceration * 1  0/28 (0.00%)  1/26 (3.85%) 
Skin Hyperpigmentation * 1  1/28 (3.57%)  0/26 (0.00%) 
Rash Acneiform * 1  2/28 (7.14%)  1/26 (3.85%) 
Pruritus * 1  0/28 (0.00%)  3/26 (11.54%) 
Photosensitivity * 1  1/28 (3.57%)  1/26 (3.85%) 
Rash Maculo-Papular * 1  3/28 (10.71%)  3/26 (11.54%) 
Dry Skin * 1  1/28 (3.57%)  3/26 (11.54%) 
Alopecia * 1  7/28 (25.00%)  5/26 (19.23%) 
Vascular disorders     
Thromboembolic Event * 1  1/28 (3.57%)  0/26 (0.00%) 
Phlebitis * 1  1/28 (3.57%)  0/26 (0.00%) 
Hypotension * 1  0/28 (0.00%)  1/26 (3.85%) 
Hypertension * 1  1/28 (3.57%)  1/26 (3.85%) 
Hot Flashes * 1  3/28 (10.71%)  1/26 (3.85%) 
Flushing * 1  0/28 (0.00%)  2/26 (7.69%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Early closure leading to non-compliance and small numbers of subjects analyzed. Study cannot be considered terminated because some participants are still being examined for follow-up.
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
Layout table for Results Point of Contact information
Name/Title: Linda Gedeon for Virginia Filiaci, PhD.
Organization: NRG Oncology
Phone: 716-845-1169
EMail: lgedeon@gogstats.org
Layout table for additonal information
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01535053     History of Changes
Other Study ID Numbers: GOG-0275
NCI-2012-00250 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000725211
GOG-0275
PGOG-0275_A08PAMDREVW01
GOG-0275 ( Other Identifier: NRG Oncology )
GOG-0275 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: February 14, 2012
First Posted: February 17, 2012
Results First Submitted: March 8, 2019
Results First Posted: August 13, 2019
Last Update Posted: August 13, 2019