Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Granisetron to Prevent Nausea and Vomiting After Chemotherapy in Patients With Malignant Disease

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care, Treatment Closed 18 and over NCI, Pharmaceutical / Industry UCLA-9904005 SB-BRL43694A/513, NCI-G00-1674, NCT00005024

Objectives

I.  Compare the efficacy and safety of oral granisetron versus placebo in
preventing nausea and vomiting during the 48 hours that begins 24 hours after
administration of cyclophosphamide-based or carboplatin-based chemotherapy
regimens in patients with malignant disease.

Entry Criteria

Disease Characteristics:

Diagnosis of malignant disease eligible for chemotherapy

Scheduled to receive a regimen of chemotherapy containing IV cyclophosphamide
or carboplatin, with or without other chemotherapy agents
 Cyclophosphamide must be given at a dose of 500-1,200 mg/m2
 Carboplatin must be given at a dose of at least 300 mg/m2 unless Calvert
  dosing equation (using target AUC of 6 mg/mL/min) requires less than 300
  mg/m2
 Doxorubicin, if given, must be infused within a period not exceeding 1 hour
 Minimum doses are to be based on actual body weight
 Other emetogenic or nonemetogenic agents are permitted to be included in the
  day 0 chemotherapy regimen without restriction on dose
 Emetogenic agents must be given as part of cyclophosphamide-based or
  carboplatin-based regimen on day 0 and not at another time within the 72
  hour period
 Cyclophosphamide, carboplatin, or doxorubicin must be the first emetogenic
  agent given
 No cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen 

No primary or secondary (from metastatic disease) brain neoplasm with:
 Signs or symptoms of increased intracranial pressure OR
 Brain metastases requiring treatment within 30 days of study entry

No signs or symptoms of cerebral edema

Symptomatically "silent" metastasis allowed

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 See Disease Characteristics
 No prior emetogenic chemotherapy
 Prior nonemetogenic chemotherapy (dose and/or agent) allowed provided
  antiemetic agents were not required and nausea and emesis did not result

Endocrine therapy:
 No chronic (more than 1 month) or concurrent corticosteroids except for
  replacement or maintenance doses up to 10 mg prednisone or equivalent or
  prophylactic pretherapy with dexamethasone on day 0 

Radiotherapy:
 At least 24 hours since prior radiotherapy to any abdominal field (T10-L5)
 No concurrent radiotherapy to any abdominal field (T10-L5)
 Prior or concurrent radiotherapy to other fields allowed (e.g., pelvic
  irradiation, thoracic irradiation)

Surgery:
 Not specified

Other:
 At least 30 days or 5 half-lives (whichever is longer) since prior
  investigational drugs
 At least 8 hours since prior other short acting agents administered for
  procedures (e.g., port insertion)
 At least 8 hours since prior and no concurrent benzodiazepines
 Concurrent narcotic analgesics allowed provided receiving for at least 1 week
  prior with no nausea or emesis
 No chronic (more than 1 month) or concurrent agents known to have a
  significant effect on emesis (e.g., antipsychotics, cannabinoids,
  metoclopramide, and 5HT3 receptor antagonists)
 No other concurrent prophylactic antiemetics

Patient Characteristics:

Age:
 18 and over

Performance status:
 Karnofsky 60-100%

Life expectancy:
 Not specified

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified

Other:
 Not pregnant or nursing
 Negative pregnancy test
 Fertile patients must use effective contraception
 No unstable medical disorder
 No known hypersensitivity to any 5HT3 receptor antagonist
 At least 1 hour since prior nausea and/or at least 24 hours since prior
  emesis (i.e., vomiting and/or retching)

Expected Enrollment

A total of 434 patients (217 per arm) will be accrued for this study.

Outline

This is a randomized, double blind, placebo controlled, parallel, multicenter
study.  Patients are randomized to one of two treatment arms.

Arm I:  Patients receive oral granisetron on day 0 at 60 minutes prior to the
scheduled administration of IV cyclophosphamide or carboplatin (or 
doxorubicin) chemotherapy.  On days 1 and 2, patients receive oral granisetron 
at approximately the same time as on day 0.

Arm II:  Patients receive oral granisetron on day 0 as in arm I.  On days 1 
and 2, patients receive oral placebo at approximately the same time as the
granisetron tablets were taken on day 0.

Patients are followed between 5 and 11 days after the last dose of study
medication.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Barbara Gitlitz, MD, Protocol chair(Contact information may not be current)		Ph: 310-825-5268; 888-798-0719

Registry Information
Official Title		A Double-blind, Multicenter, Parallel Study Comparing the Efficacy and Safety of Kytril Tablets with Placebo, in the Prevention of Nausea and Vomiting During the Days Following Administration of IV Cyclophosphamide-based or Carboplatin-based Chemotherapy in Patients with Malignant Disease
Registered in ClinicalTrials.gov		NCT00005024
Date Submitted to PDQ		2000-01-07
Information Last Verified		2007-06-01