Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
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
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.
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.
;
Allocation: Randomized, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01828775 -
Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment
|
N/A | |
| Terminated |
NCT01642342 -
Recombinant Albumin Fusion Protein sEphB4-HSA in Treating Patients With Metastatic or Recurrent Solid Tumors
|
Phase 1 | |
| Completed |
NCT00002950 -
Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01705548 -
Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
|
N/A | |
| Completed |
NCT02146222 -
VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Docetaxel in Treating Patients With Solid Tumors
|
Phase 1 | |
| Terminated |
NCT01602627 -
Hsp90 Inhibitor AUY922 in Treating Older Patients With Advanced Solid Malignancies
|
Phase 1 | |
| Completed |
NCT01191216 -
1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT00992303 -
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants
|
||
| Recruiting |
NCT01137825 -
Registry of Older Patients With Cancer
|
||
| Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
| Completed |
NCT00949949 -
Everolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy
|
Phase 1 | |
| Completed |
NCT00924651 -
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
|
Phase 3 | |
| Withdrawn |
NCT00937417 -
S0716 Vandetanib and Docetaxel in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT00710632 -
Screening to Predict Weight Loss in Patients With Cancer
|
N/A | |
| Completed |
NCT00573690 -
Sorafenib Combined With Cisplatin and Etoposide or Carboplatin and Pemetrexed in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT00544596 -
R-(-)-Gossypol Acetic Acid, Cisplatin, and Etoposide in Treating Patients With Advanced Solid Tumors or Extensive Stage Small Cell Lung Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT00436735 -
Nelfinavir in Treating Patients With Metastatic, Refractory, or Recurrent Solid Tumors
|
Phase 1 | |
| Completed |
NCT00352443 -
S0528 Lapatinib and Everolimus in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Completed |
NCT00121277 -
Vorinostat and Capecitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
|
Phase 1 | |
| Completed |
NCT00126620 -
Sorafenib and Erlotinib in Treating Patients With Metastatic or Unresectable Solid Tumors
|
Phase 1 |