Trial record 1 of 1 for:    gog 0273
Previous Study | Return to List | Next Study

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01366183
First received: June 2, 2011
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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 Intervention
Stage I Ovarian Epithelial Cancer
Stage I Primary Peritoneal Cavity Cancer
Stage IA Fallopian Tube Cancer
Stage IB Fallopian Tube Cancer
Stage IC Fallopian Tube Cancer
Stage II Ovarian Epithelial Cancer
Stage II Primary Peritoneal Cavity Cancer
Stage IIA Fallopian Tube Cancer
Stage IIB Fallopian Tube Cancer
Stage IIC Fallopian Tube Cancer
Stage III Ovarian Epithelial Cancer
Stage III Primary Peritoneal Cavity Cancer
Stage IIIA Fallopian Tube Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIC Fallopian Tube Cancer
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Epithelial Cancer
Stage IV Primary Peritoneal Cavity Cancer
Other: pharmacological study
Other: questionnaire administration
Procedure: assessment of therapy complications
Other: quality-of-life assessment
Drug: carboplatin
Drug: paclitaxel
Biological: filgrastim

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chemotherapy Toxicity in Elderly Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Changes in comorbidity index measured by the Charlson scale [ Time Frame: Baseline to up to 6 weeks after completion of course 4 ] [ Designated as safety issue: No ]
  • Changes in nutritional status measured by weight [ Time Frame: Baseline to up to 6 weeks after completion of course 4 ] [ Designated as safety issue: No ]
    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.

  • Clinical response of elderly patients with ovarian, primary peritoneal cavity, or fallopian tube cancer [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 290
Study Start Date: August 2011
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: questionnaire administration
Ancillary studies
Procedure: assessment of therapy complications
Undergo nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment assessments
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Drug: carboplatin
Undergo chemotherapy
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: paclitaxel
Undergo chemotherapy
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Biological: filgrastim
Undergo chemotherapy
Other Names:
  • G-CSF
  • Neupogen

Detailed Description:

PRIMARY OBJECTIVES:

l. To determine whether the score on Instrumental Activities of Daily Living (IADL) obtained prior to treatment is associated with the ability of patients to complete four cycles of chemotherapy without dose reduction or a more than 7-day delay.

II. To estimate by regimen the percentage of patients who are able to complete four cycles of chemotherapy regardless of dose reductions and delays.

III. To compare actual and calculated carboplatin area under the curve (AUC) in this patient population.

SECONDARY OBJECTIVES:

I. To describe the percentage of patients who are entered after primary surgery versus those entered to receive primary or neoadjuvant chemotherapy, the percentage of patients who are treated with each allowed regimen, and the percentage of patients who eventually receive surgery in the primary chemotherapy group.

II. To determine whether the need for assistance with IADLs at time of registration is associated with choice of chemotherapy regimen (in both primary chemotherapy and primary surgery patients).

III. To explore whether age, baseline scores on the geriatric measures (functional status, nutritional status, or co-morbidity) and quality-of-life (QOL) are correlated with likelihood of completing four courses of chemotherapy without dose reduction or a more than 7-day delay.

IV. To explore reasons for and timing of dose reductions and delays. V. To describe toxicities, pre-/post-chemotherapy QOL, and pre-/post-chemotherapy scores on geriatric measures in this patient population.

TERTIARY OBJECTIVES:

I. To explore potential relationships of carboplatin AUC, paclitaxel clearance, and paclitaxel time above a plasma concentration of 0.05 mcM to nadir neutrophil and platelet counts during course 1 of treatment.

II. To explore the association between baseline IADL and survival. III. To explore the association between IADL and the functional well-being (FWB) subscale in the Functional Assessment of Cancer Therapy - Ovary (FACT-O).

OUTLINE:

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 Functional Assessment of Cancer Treatment - Neurotoxicity (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.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Elderly woman with ovarian, fallopian tube or primary peritoneal cancer

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366183

  Show 363 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Vivian von Gruenigen Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01366183     History of Changes
Other Study ID Numbers: GOG-0273, NCI-2011-02900, GOG-0273, GOG-0273, GOG-0273, U10CA101165
Study First Received: June 2, 2011
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Paclitaxel
Lenograstim
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 19, 2014