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

NCT ID: NCT00005024

Last Updated: 2014-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL

Brief Summary

RATIONALE: Antiemetic drugs such as granisetron may help to prevent nausea and vomiting in patients treated with chemotherapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of granisetron with that of a placebo in preventing nausea and vomiting after chemotherapy in patients who have malignant disease.

Detailed Description

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.

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.

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

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

carboplatin

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

granisetron hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Barbara J. Gitlitz, MD

Role: STUDY_CHAIR

Jonsson Comprehensive Cancer Center

Other Identifiers

UCLA-9904005

Identifier Type: -

Identifier Source: secondary_id

SB-BRL43694A/513

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1674

Identifier Type: -

Identifier Source: secondary_id

CDR0000067540

Identifier Type: -

Identifier Source: org_study_id