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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedNatural history/EpidemiologyClosed70 and overNCI, OtherGOG-0273
NCI-2011-02900, U10CA101165, NCT01366183

Trial Description


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.

Further Study Information


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.


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.


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).


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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

National Cancer Institute

Vivian von GruenigenPrincipal Investigator

Trial Sites

 GOG of Arizona, PC
 Vivian von Gruenigen Ph: 330-379-3514
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard M. Gross Ph: 765-983-3000
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-3456
North Dakota
 Bismarck Cancer Center
 John T Reynolds Ph: 701-323-5760
 M. D. Anderson Cancer Center at University of Texas
 Jubilee Brown Ph: 713-792-3245

Link to the current record.
NLM Identifer NCT01366183 processed this data on April 09, 2015

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to

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