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Trial record 3 of 10 for:    "Cervical Adenocarcinoma" | "Topotecan"

Veliparib, Topotecan Hydrochloride, and Filgrastim or Pegfilgrastim in Treating Patients With Persistent or Recurrent Cervical Cancer

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: NCT01266447
Recruitment Status : Completed
First Posted : December 24, 2010
Results First Posted : February 1, 2017
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
NRG Oncology
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Small Cell Carcinoma
Cervical Squamous Cell Carcinoma
Recurrent Cervical Carcinoma
Stage III Cervical Cancer
Stage IVA Cervical Cancer
Stage IVB Cervical Cancer
Interventions Biological: Filgrastim
Other: Laboratory Biomarker Analysis
Biological: Pegfilgrastim
Drug: Topotecan Hydrochloride
Drug: Veliparib
Enrollment 27
Recruitment Details The study was activated on 2/7/2011 and closed to accrual on 1/17/2013.
Pre-assignment Details  
Arm/Group Title ABT-888, Topotecan and Filgrastim or Pegfilgrastim
Hide Arm/Group Description ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Period Title: Overall Study
Started 27
Completed 27 [1]
Not Completed 0
[1]
Eligible and treated patients
Arm/Group Title ABT-888, Topotecan and Filgrastim or Pegfilgrastim
Hide Arm/Group Description ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
Eligible and treated patients
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
  92.6%
>=65 years
2
   7.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
49.8  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
27
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title Tumor Response
Hide Description Complete and Partial Tumor Response as Assessed by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), at least 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.
Time Frame Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicted based on symptoms or physical signs suggestive of progressive disease. The average time was 2.3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and Treated Patients
Arm/Group Title ABT-888, Topotecan and Filgrastim or Pegfilgrastim
Hide Arm/Group Description:
ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Overall Number of Participants Analyzed 27
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
7.4
(2 to 100)
2.Primary Outcome
Title Number of Patients With Dose-limiting Toxicities (in Safety lead-in)
Hide Description A dose-limiting toxicity (DLT) is assessed by NCI CTCAE v4, occurring during cycle 1 of therapy.: A dose-limiting toxicity (DLT) is defined as either hematologic or non-hematologic toxicity assessed by NCI CTCAE v4, occurring during cycle 1 of therapy, which cause any of the following: For hematologic toxicity - dose delay of greater than 2 weeks due to failure to recover counts, Treatment related febrile neutropenia, grade 4 neutropenia lasting >7 days, treatment related grade 4 thrombocytopenia or clinically significant bleeding with grade 3 thrombocytopenia. For non-hematologic toxicity; study treatment related grade 3 or 4 non-hematological toxicity (excluding anorexia, constipation, fatigue, hypersensitivity/allergic reaction to one of the study drugs, nausea & vomiting, and grade 3 dehydration), grade 4 nausea and vomiting for >48 hours despite maximum medical management, electrolyte imbalance of > or equal to grade 3 that can be replaced within 48 hours; any drug related death
Time Frame Up to 21 days
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Hide Analysis Population Description
The first 6 eligible and treated patients who completed the 1st cycle of study treatment or had a DLT prior to completing the first cycle of study treatment
Arm/Group Title ABT-888, Topotecan and Filgrastim or Pegfilgrastim
Hide Arm/Group Description:
ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
1
3.Primary Outcome
Title Adverse Events (Grade 3 or Higher) During Treatment Period
Hide Description Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
Time Frame During treatment period and up to 30 days after stopping the study treatment.The average of study treatment time was 2.3 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients - No statistical analysis provided for adverse events (grade 3 or higher) during treatment period.
Arm/Group Title ABT-888, Topotecan and Filgrastim or Pegfilgrastim
Hide Arm/Group Description:
ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: Participants
Leukopenia 6
Thrombocytopenia 12
Neutropenia 5
Anemia 16
Other Investigations 4
Cardiac Disorders 1
Gastrointestinal Disorders 7
General Disorders & administration site conditions 5
Infections and Infestations 4
Metabolism and nutrition disorders 3
Musculoskeletal and connective tissue disorders 5
Neoplasms benign, malignant and unspecified 1
Nervous system disorders 1
Renal and urinary disorders 0
Reproductive system and breast disorders 2
Respiratory, thoracic and mediastinal disorders 4
Surgical and medical procedures 1
Vascular disorders 3
4.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression.
Time Frame From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and Treated Patients
Arm/Group Title ABT-888, Topotecan and Filgrastim or Pegfilgrastim
Hide Arm/Group Description:
ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Overall Number of Participants Analyzed 27
Median (95% Confidence Interval)
Unit of Measure: months
2.0
(1.3 to 3.4)
5.Secondary Outcome
Title Overall Survival
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 From study entry to death or last contact, up to 5 years of follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and Treated Patients
Arm/Group Title ABT-888, Topotecan and Filgrastim or Pegfilgrastim
Hide Arm/Group Description:
ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Overall Number of Participants Analyzed 27
Median (95% Confidence Interval)
Unit of Measure: months
8.2
(5.8 to 10.6)
6.Secondary Outcome
Title Duration of Objective Response
Hide Description Duration of objective response is defined as the duration from the time measurement criteria is met for partial or complete response by RECIST 1.1, whichever is first recorded, until the first date the recurrent or progressive disease is objectively documented. Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), at least 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.
Time Frame Every other cycle for first 6 months; then every 3 months until disease progression confirmed; and at any other time if clinically indicated based on symptoms or signs suggestive of progressive disease.The average of study treatment time was 2.3 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and Treated Patients with objective response
Arm/Group Title ABT-888, Topotecan and Filgrastim or Pegfilgrastim
Hide Arm/Group Description:
ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Overall Number of Participants Analyzed 2
Median (Full Range)
Unit of Measure: Months
5.3
(4.0 to 6.7)
Time Frame During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ABT-888, Topotecan and Filgrastim or Pegfilgrastim
Hide Arm/Group Description ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
All-Cause Mortality
ABT-888, Topotecan and Filgrastim or Pegfilgrastim
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ABT-888, Topotecan and Filgrastim or Pegfilgrastim
Affected / at Risk (%) # Events
Total   16/27 (59.26%)    
Cardiac disorders   
Heart Failure * 1  1/27 (3.70%)  1
Gastrointestinal disorders   
Vomiting * 1  1/27 (3.70%)  1
Upper Gastrointestinal Hemorrhage * 1  1/27 (3.70%)  1
Small Intestinal Perforation * 1  1/27 (3.70%)  1
Small Intestinal Obstruction * 1  1/27 (3.70%)  1
Abdominal Pain * 1  2/27 (7.41%)  2
General disorders   
Death Nos * 1  2/27 (7.41%)  2
Infections and infestations   
Infections And Infestations - Other * 1  1/27 (3.70%)  1
Sepsis * 1  1/27 (3.70%)  1
Urinary Tract Infection * 1  1/27 (3.70%)  1
Investigations   
Platelet Count Decreased * 1  2/27 (7.41%)  2
Metabolism and nutrition disorders   
Hypokalemia * 1  1/27 (3.70%)  1
Musculoskeletal and connective tissue disorders   
Pain In Extremity * 1  1/27 (3.70%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms Benign, Malignant And Unspecified (Incl * 1  1/27 (3.70%)  1
Reproductive system and breast disorders   
Pelvic Pain * 1  1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory, Thoracic And Mediastinal Disorders * 1  1/27 (3.70%)  1
Respiratory Failure * 1  1/27 (3.70%)  1
Surgical and medical procedures   
Surgical And Medical Procedures - Other * 1  1/27 (3.70%)  1
Vascular disorders   
Thromboembolic Event * 1  1/27 (3.70%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE 4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ABT-888, Topotecan and Filgrastim or Pegfilgrastim
Affected / at Risk (%) # Events
Total   27/27 (100.00%)    
Blood and lymphatic system disorders   
Anemia * 1  27/27 (100.00%) 
Cardiac disorders   
Heart Failure * 1  1/27 (3.70%) 
Sinus Tachycardia * 1  1/27 (3.70%) 
Ear and labyrinth disorders   
Ear And Labyrinth Disorders - Other * 1  1/27 (3.70%) 
Tinnitus * 1  1/27 (3.70%) 
Ear Pain * 1  1/27 (3.70%) 
Endocrine disorders   
Endocrine Disorders - Other * 1  1/27 (3.70%) 
Gastrointestinal disorders   
Dysphagia * 1  1/27 (3.70%) 
Dyspepsia * 1  1/27 (3.70%) 
Dry Mouth * 1  1/27 (3.70%) 
Constipation * 1  10/27 (37.04%) 
Diarrhea * 1  7/27 (25.93%) 
Vomiting * 1  8/27 (29.63%) 
Salivary Duct Inflammation * 1  2/27 (7.41%) 
Abdominal Pain * 1  7/27 (25.93%) 
Rectal Hemorrhage * 1  2/27 (7.41%) 
Mucositis Oral * 1  1/27 (3.70%) 
Lower Gastrointestinal Hemorrhage * 1  1/27 (3.70%) 
Nausea * 1  15/27 (55.56%) 
Hemorrhoidal Hemorrhage * 1  1/27 (3.70%) 
Ascites * 1  1/27 (3.70%) 
Flatulence * 1  1/27 (3.70%) 
General disorders   
General Disorders And Administration Site Conditio * 1  1/27 (3.70%) 
Pain * 1  7/27 (25.93%) 
Malaise * 1  1/27 (3.70%) 
Localized Edema * 1  1/27 (3.70%) 
Non-Cardiac Chest Pain * 1  2/27 (7.41%) 
Edema Limbs * 1  2/27 (7.41%) 
Fatigue * 1  22/27 (81.48%) 
Fever * 1  3/27 (11.11%) 
Chills * 1  1/27 (3.70%) 
Infections and infestations   
Infections And Infestations - Other * 1  1/27 (3.70%) 
Upper Respiratory Infection * 1  1/27 (3.70%) 
Skin Infection * 1  1/27 (3.70%) 
Sinusitis * 1  1/27 (3.70%) 
Sepsis * 1  1/27 (3.70%) 
Vaginal Infection * 1  1/27 (3.70%) 
Urinary Tract Infection * 1  5/27 (18.52%) 
Lip Infection * 1  1/27 (3.70%) 
Injury, poisoning and procedural complications   
Fracture * 1  1/27 (3.70%) 
Fall * 1  1/27 (3.70%) 
Bruising * 1  4/27 (14.81%) 
Investigations   
Weight Loss * 1  1/27 (3.70%) 
Weight Gain * 1  2/27 (7.41%) 
Platelet Count Decreased * 1  23/27 (85.19%) 
Lymphocyte Count Decreased * 1  4/27 (14.81%) 
Inr Increased * 1  1/27 (3.70%) 
Ggt Increased * 1  1/27 (3.70%) 
Creatinine Increased * 1  3/27 (11.11%) 
Neutrophil Count Decreased * 1  12/27 (44.44%) 
Blood Bilirubin Increased * 1  2/27 (7.41%) 
White Blood Cell Decreased * 1  15/27 (55.56%) 
Aspartate Aminotransferase Increased * 1  2/27 (7.41%) 
Alkaline Phosphatase Increased * 1  8/27 (29.63%) 
Alanine Aminotransferase Increased * 1  1/27 (3.70%) 
Activated Partial Thromboplastin Time Prolonged * 1  1/27 (3.70%) 
Metabolism and nutrition disorders   
Hypophosphatemia * 1  1/27 (3.70%) 
Hyponatremia * 1  3/27 (11.11%) 
Hypomagnesemia * 1  8/27 (29.63%) 
Hypokalemia * 1  10/27 (37.04%) 
Hypoglycemia * 1  1/27 (3.70%) 
Hypocalcemia * 1  6/27 (22.22%) 
Hypoalbuminemia * 1  8/27 (29.63%) 
Hypernatremia * 1  1/27 (3.70%) 
Hyperkalemia * 1  2/27 (7.41%) 
Hyperglycemia * 1  7/27 (25.93%) 
Anorexia * 1  9/27 (33.33%) 
Musculoskeletal and connective tissue disorders   
Pain In Extremity * 1  4/27 (14.81%) 
Myalgia * 1  2/27 (7.41%) 
Musculoskeletal Deformity * 1  1/27 (3.70%) 
Generalized Muscle Weakness * 1  1/27 (3.70%) 
Flank Pain * 1  2/27 (7.41%) 
Bone Pain * 1  1/27 (3.70%) 
Back Pain * 1  6/27 (22.22%) 
Arthralgia * 1  3/27 (11.11%) 
Musculoskeletal And Connective Tissue Disorder - * 1  1/27 (3.70%) 
Nervous system disorders   
Peripheral Sensory Neuropathy * 1  8/27 (29.63%) 
Peripheral Motor Neuropathy * 1  2/27 (7.41%) 
Memory Impairment * 1  2/27 (7.41%) 
Lethargy * 1  1/27 (3.70%) 
Headache * 1  5/27 (18.52%) 
Dysgeusia * 1  3/27 (11.11%) 
Dysarthria * 1  1/27 (3.70%) 
Dizziness * 1  4/27 (14.81%) 
Depressed Level Of Consciousness * 1  1/27 (3.70%) 
Ataxia * 1  1/27 (3.70%) 
Psychiatric disorders   
Insomnia * 1  6/27 (22.22%) 
Depression * 1  4/27 (14.81%) 
Confusion * 1  1/27 (3.70%) 
Anxiety * 1  1/27 (3.70%) 
Agitation * 1  1/27 (3.70%) 
Renal and urinary disorders   
Urinary Tract Obstruction * 1  1/27 (3.70%) 
Urinary Incontinence * 1  1/27 (3.70%) 
Proteinuria * 1  1/27 (3.70%) 
Hematuria * 1  3/27 (11.11%) 
Cystitis Noninfective * 1  1/27 (3.70%) 
Reproductive system and breast disorders   
Vaginal Hemorrhage * 1  2/27 (7.41%) 
Pelvic Pain * 1  2/27 (7.41%) 
Vaginal Discharge * 1  1/27 (3.70%) 
Respiratory, thoracic and mediastinal disorders   
Postnasal Drip * 1  2/27 (7.41%) 
Pleural Effusion * 1  2/27 (7.41%) 
Nasal Congestion * 1  2/27 (7.41%) 
Productive Cough * 1  1/27 (3.70%) 
Hoarseness * 1  1/27 (3.70%) 
Dyspnea * 1  8/27 (29.63%) 
Cough * 1  6/27 (22.22%) 
Atelectasis * 1  1/27 (3.70%) 
Allergic Rhinitis * 1  2/27 (7.41%) 
Skin and subcutaneous tissue disorders   
Skin And Subcutaneous Tissue Disorders - Other * 1  1/27 (3.70%) 
Rash Maculo-Papular * 1  2/27 (7.41%) 
Hyperhidrosis * 1  1/27 (3.70%) 
Erythema Multiforme * 1  1/27 (3.70%) 
Dry Skin * 1  2/27 (7.41%) 
Alopecia * 1  11/27 (40.74%) 
Vascular disorders   
Vascular Disorders - Other * 1  1/27 (3.70%) 
Thromboembolic Event * 1  4/27 (14.81%) 
Lymphedema * 1  3/27 (11.11%) 
Hypotension * 1  3/27 (11.11%) 
Hypertension * 1  2/27 (7.41%) 
Hot Flashes * 1  3/27 (11.11%) 
Flushing * 1  1/27 (3.70%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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: Linda Gedeon, Clinical Data Coordinator
Organization: NRG Oncology
Phone: 716-845-1169
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01266447     History of Changes
Other Study ID Numbers: NCI-2011-02659
NCI-2011-02659 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0127W
CDR0000691281
GOG-0127W ( Other Identifier: NRG Oncology )
GOG-0127W ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: December 23, 2010
First Posted: December 24, 2010
Results First Submitted: December 7, 2016
Results First Posted: February 1, 2017
Last Update Posted: August 8, 2019