Carboplatin and Gemcitabine in Treating Patients With Advanced Solid Tumors

NCT00021346 | Completed Phase 1

• 4 other identifiers: CDR0000068771P30CA006927FCCC-97028NCI-G01-1984
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and gemcitabine in treating patients who have advanced solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

carboplatin DRUG

gemcitabine hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor for which no standard therapy exists No untreated brain metastases with evidence of neurologic deterioration or CNS progression PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: More than 3 months Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Other: No serious concurrent infection No other serious concurrent medical illness that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 2 prior systemic chemotherapy regimens for advanced disease Prior adjuvant or induction therapy for initial disease allowed At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or melphalan) No prior combination carboplatin and gemcitabine Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to more than 30% of bone marrow At least 4 weeks since prior radiotherapy Surgery: Not specified

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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Interventions

Carboplatin; Gemcitabine

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Corey J. Langer, MD

  Fox Chase Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: April 22, 2004
• Study Start: November 1, 1997
• Primary Completion: July 1, 2001
• Study Completion: March 1, 2002
• Last Updated: April 17, 2013

Record last verified: 2013-04

Locations

US (1)