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Chemotherapy Toxicity On Quality of Life in Older Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer

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ClinicalTrials.gov Identifier: NCT01366183
Recruitment Status : Unknown
Verified March 2019 by GOG Foundation ( Gynecologic Oncology Group ).
Recruitment status was:  Active, not recruiting
First Posted : June 3, 2011
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation ( Gynecologic Oncology Group )

Study Description
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Brief Summary:
This trial studies the chemotherapy toxicity on quality of life in older patients with stage I, stage II, stage III, or stage IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Learning about the side effects of chemotherapy in older patients may help doctors plan better ways to treat cancer.

Condition or disease Intervention/treatment
Stage I Ovarian Cancer AJCC v6 and v7 Stage IA Fallopian Tube Cancer AJCC v6 and v7 Stage IB Fallopian Tube Cancer AJCC v6 and v7 Stage IC Fallopian Tube Cancer AJCC v6 and v7 Stage II Ovarian Cancer AJCC v6 and v7 Stage IIA Fallopian Tube Cancer AJCC v6 and v7 Stage IIB Fallopian Tube Cancer AJCC v6 and v7 Stage IIC Fallopian Tube Cancer AJCC v6 and v7 Stage III Ovarian Cancer AJCC v6 and v7 Stage III Primary Peritoneal Cancer AJCC v7 Stage IIIA Fallopian Tube Cancer AJCC v7 Stage IIIB Fallopian Tube Cancer AJCC v7 Stage IIIC Fallopian Tube Cancer AJCC v7 Stage IV Fallopian Tube Cancer AJCC v6 and v7 Stage IV Ovarian Cancer AJCC v6 and v7 Stage IV Primary Peritoneal Cancer AJCC v7 Procedure: Assessment of Therapy Complications Drug: Carboplatin Biological: Filgrastim Drug: Paclitaxel Other: Pharmacological Study Other: Quality-of-Life Assessment Other: Questionnaire Administration

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Study Design
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Study Type : Observational
Estimated Enrollment : 290 participants
Official Title: Chemotherapy Toxicity in Elderly Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Actual Study Start Date : August 15, 2011
Estimated Primary Completion Date : December 31, 2019

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Observational (quality of life questionnaire)

Patients receive chemotherapy comprising carboplatin, paclitaxel, and filgrastim (regimen 1) or carboplatin alone (regimen 2) every 21 days for 4 courses according to their physicians and/or patients' choice. Patients may undergo surgery and/or further chemotherapy at the discretion of treating physician. Patients undergo blood sample collection at baseline and periodically during course 1 for pharmacokinetic studies.

Patients' quality of life is assessed by the FACT-O, the FACT-Ntx subscale, the IADL, and the Ability to Complete Social Activity questionnaires at baseline, prior to courses 1 and 3, and then 3-6 weeks after completion of course 4. Nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment are also assessed.

 Procedure: Assessment of Therapy Complications
Undergo nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment assessments

Drug: Carboplatin
Undergo chemotherapy
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Biological: Filgrastim
Undergo chemotherapy
Other Names:
  • FILGRASTIM, LICENSE HOLDER UNSPECIFIED
  • G-CSF
  • Neupogen
  • r-metHuG-CSF
  • Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
  • rG-CSF
  • Tevagrastim

Drug: Paclitaxel
Undergo chemotherapy
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat

Other: Pharmacological Study
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Tolerance to study treatment, defined as completing four cycles of study treatment, without dose reductions or treatment delays of over seven days [ Time Frame: Up to 5 years ]
    Will be modeled with logistic regression using baseline IADL scores as a covariate. Exploratory analysis will evaluate baseline IADL scores adjusting for covariates such as: Charlson scale, nutritional status, or age.

  2. Percent of women, who are 70 years or older, able to complete at least 4 cycles of treatment regardless of dose reduction and delays [ Time Frame: Up to 5 years ]
    While this percentage will be estimated for each study regimen separately, the targeted sample size will limit the width of the 95%-confidence interval for the marginal percentage so that it is no larger than 0.15.


Secondary Outcome Measures :
  1. Changes in quality-of-life measured by FACT-O, FACT/GOG-Ntx-4 subscale, IADL, and ADL [ Time Frame: Baseline to up to 6 weeks after completion of course 4 ]
    The changes in FACT-O, FACT/GOG-Ntx-4 subscale, IADL, and ADL will be summarized descriptively as the differences of scores between pre and post chemotherapy. Assuming 80% of patients complete the assessment at the completion of chemotherapy, then a sample of 148 patients will provide 90% power to detect 5 unit changes in FACT-O, 0.5 unit change in FACT/GOG-Ntx subscale score, 1 unit change in IADL or ADL score using paired t-test at significant level of 0.05.

  2. Changes in comorbidity index measured by the Charlson scale [ Time Frame: Baseline to up to 6 weeks after completion of course 4 ]
  3. Changes in nutritional status measured by weight [ Time Frame: Baseline to up to 6 weeks after completion of course 4 ]
    The changes in weight will be summarized descriptively as the differences of scores between pre and post chemotherapy. The change of nutritional status after completing chemotherapy will be examined using McNemar?s test.

  4. Clinical response of elderly patients with ovarian, primary peritoneal cavity, or fallopian tube cancer [ Time Frame: Up to 5 years ]
  5. Percent of patients reporting adverse events as assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events [ Time Frame: Up to 6 weeks after course 4 ]
    The probability of an adverse event will be estimated as the percent of patients reporting an adverse event out of all patients beginning treatment.


Other Outcome Measures:
  1. Pharmacokinetic parameters including paclitaxel AUC, carboplatin AUC, paclitaxel total body clearance, and time that plasma paclitaxel concentration remains above threshold 0.05 uM/L [ Time Frame: Pre-dose, 1, 6, and 24 hours ]
    The observed pharmacokinetics of paclitaxel and carboplatin will be compared with published pharmacokinetic measures of paclitaxel and carboplatin in a descriptive fashion. No formal statistical testing will be performed for the comparisons.


Eligibility Criteria
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Layout table for eligibility information
Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Criteria

Inclusion Criteria:

  • Eligible patients must have a histologically or cytologically confirmed diagnosis of adenocarcinoma of the ovary, peritoneum, or fallopian tube either by surgery, biopsy, fine-needle aspiration (FNA), paracentesis, or thoracentesis; a diagnosis of a mucinous cancer must be made by biopsy only
  • International Federation of Gynecology and Obstetrics (FIGO) stage I, II, III, and IV are eligible
  • Patients must have received no previous treatment for this malignancy other than surgery
  • Patients must be entered within eight weeks of confirmation of disease diagnosis by surgery, biopsy, FNA, paracentesis or thoracentesis if there is no primary surgery, and within twelve weeks of primary or staging surgery if patient received primary surgery
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
  • Platelets greater than or equal to 100,000/mcl
  • Bilirubin less than or equal upper limit of normal (ULN)
  • Creatinine less than or equal to 1.5 x ULN
  • Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, 2 or 3
  • Effective XX/XX/2014, only patients 75 years of age or older are eligible for enrollment; (04/23/2012) (08/12/2013)
  • Patients must have recovered from the effects of recent surgery
  • Patients must be free of active infection requiring antibiotics
  • Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA)
  • Patient and physician agree that they plan to conduct treatment according to Regimen 3
  • Patient can read and understand sufficient English to be able to respond to questions posed by the study instruments

Exclusion Criteria:

  • Patients who have received previous treatment for this malignancy other than surgery
  • Patients with other invasive malignancies whose previous cancer treatment contraindicates this protocol therapy
  • ?Borderline tumors? (tumors of low malignant potential) by surgery or biopsy are excluded
  • Patients with medical conditions that in the opinion of the investigator render treatment on this protocol unsafe should be excluded
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366183


Locations
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Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Vivian E von Gruenigen Gynecologic Oncology Group
More Information
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Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01366183    
Other Study ID Numbers: GOG-0273
NCI-2011-02900 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0273 ( Other Identifier: Gynecologic Oncology Group )
GOG-0273 ( Other Identifier: DCP )
GOG-0273 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Paclitaxel
Carboplatin
Albumin-Bound Paclitaxel
Lenograstim
Sargramostim
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents