NCT00003072

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different combinations may kill more tumor cells. PURPOSE: Randomized phase II double-blinded trial to study the effectiveness of paclitaxel and carboplatin given with either amifostine or placebo in patients with metastatic stage III or stage IV ovarian cancer or metastatic stage III or stage IV non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Timeline
Completed

Started May 1997

Shorter than P25 for phase_2 lung-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1997

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 1998

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.9 years until next milestone

First Posted

Study publicly available on registry

September 6, 2004

Completed
Last Updated

September 21, 2012

Status Verified

September 1, 2012

Enrollment Period

1.4 years

First QC Date

November 1, 1999

Last Update Submit

September 19, 2012

Conditions

Lung CancerNeurotoxicityOvarian Cancer

Keywords

stage III non-small cell lung cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerstage IV non-small cell lung cancerneurotoxicity

Interventions

amifostine trihydrateDRUG
carboplatinDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven stage III/IV ovarian or non-small cell lung cancer PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-2 Life Expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 3.0 mg/dL Renal: Creatinine no greater than 2 mg/dL Other: Not pregnant or nursing No history of platinum, paclitaxel or amifostine hypersensitivity Prior myelosuppressive events allowed No clinically significant ascites PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy within 1 month of study Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy within 1 month of study Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Oncology Service of San Francisco General Hospital Medical Center

San Francisco, California, 94110, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94115-0128, United States

Location

UCSF/Mt. Zion Cancer Center

San Francisco, California, 94115, United States

Location

Veterans Affairs Medical Center - San Francisco

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsNeurotoxicity SyndromesOvarian NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Ovarian Epithelial

Interventions

AmifostineCarboplatinPaclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNervous System DiseasesPoisoningChemically-Induced DisordersEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinoma, BronchogenicBronchial NeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

OrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur CompoundsCoordination ComplexesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Robert J. Ignoffo, PharmD

    University of California, San Francisco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 6, 2004

Study Start

May 1, 1997

Primary Completion

October 1, 1998

Study Completion

October 1, 1998

Last Updated

September 21, 2012

Record last verified: 2012-09

Locations

US(4)